Becaplermin Gel Research Articles

Why Are There So Few FDA-Approved Therapeutics for Wound Healing?

Since the only and the milestone FDA approval of becaplermin gel (RegranexTM, 0.01% human recombinant PDGF-BB) as a (diabetic) wound healing therapeutic more than 25 years ago, no new therapeutic (excluding physical therapies, devices, dressings, anti-microbial agents, or other preventive treatments) for any type of wound healing has advanced to clinical applications. During the same period of time, the FDA has approved additional 250 new drugs for various human tumors, which were famously described as "wounds that do not heal". Two similar pathological conditions have experienced such a dramatic difference in therapeutics. More surprisingly, few in the wound healing community seem to be alarmed by this mysterious deficit. As it is often said, "damaging is far easier than re-building". In contrast to the primary duty of a cancer drug to damage a single molecule of the signaling network, a wound healing drug must be able to re-build the multi-level damages in the wound. No known single molecule alone is capable of repairing multi-cell-type and multi-pathway damages all at once. We argue that the previous single molecule-based strategy for developing wound healing therapeutics is profoundly flawed in theory. The future success of effective wound healing therapeutics requires a fundamental change in the paradigm.

Topical Biological Agents as Adjuncts to Improve Wound Healing in Chronic Diabetic Wounds: A Systematic Review of Clinical Evidence and Future Directions.

Diabetes is a leading chronic illness in the modern world and 19-34% develop chronic diabetic foot ulcers (DFUs) in their lifetime, often necessitating amputation. The reduction in tissue growth factors and resulting imbalance between proteolytic enzymes and their inhibitors, along with systemic factors impairing healing appear particularly important in chronic wounds. Growth factors applied topically have thus been suggested to be a non-invasive, safe, and cost-effective adjunct to improve wound healing and prevent complications.Comprehensive database searches of MEDLINE via PubMed, EMBASE, Cochrane, and ClinicalTrials.gov were performed to identify clinical evidence and ongoing trials. The risk of bias analysis included randomized controlled trials (RCTs) was performed using the Cochrane Risk of Bias 2.0 tool. We included randomized controlled trials that compared the use of a topical biologic growth factor-containing regimen to any other regimen. Primary outcomes of interest were time to wound closure, healing rate, and time. Secondary outcomes included the incidence of adverse events such as infection.A total of 41 trials from 1992-2020 were included in this review, with a total recorded 3,112 patients. Platelet-derived growth factors (PDGF) in the form of becaplermin gel are likely to reduce the time of closure, increase the incidence of wound closure, and complete wound healing. Human umbilical cord-related treatments, dehydrated human amnion and chorion allograft (dHACA), and hypothermically stored amniotic membrane (HSAM), consistently increased the rates and incidence of complete ulcer healing while reducing ulcer size and time to complete ulcer healing. Fibroblast growth factor-1 (FGF1) showed only a slight benefit in multiple studies regarding increasing complete ulcer healing rates and incidence while reducing ulcer size and time to complete ulcer healing, with a few studies showing no statistical difference from placebo. Platelet-rich fibrin (PRF) is consistent in reducing the time to complete ulcer healing and increasing wound healing rate but may not reduce ulcer size or increase the incidence of complete ulcer healing.Targeting the wound healing pathway via the extrinsic administration of growth factors is a promising option to augment wound healing in diabetic patients. Growth factors have also shown promise in specific subgroups of patients who are at risk of significantly impaired wound healing such as those with a history of secondary infection and vasculopathy. As diabetes impairs multiple stages of wound healing, combining growth factors in diabetic wound care may prove to be an area of interest. Evidence from this systematic literature review suggests that topical adjuncts probably reduce time to wound closure, reduce healing time, and increase the healing rate in patients with chronic DFUs.

An integrative review of lateral line depigmentation in marine and freshwater fish.

To qualitatively review reports on lateral line depigmentation (LLD) in marine and freshwater fish. English-language publications concerning LLD published before March 1, 2020. Electronic searches of CAB abstracts, PubMed, and Web of Science databases and the proceedings of the International Association of Aquatic Animal Medicine were performed. Records were systematically screened and selected for inclusion in an integrative review. Bibliographies of records included in the review were examined to identify other records to be screened. Included records were qualitatively reviewed. Evidence level and quality were graded according to previously described criteria. Information pertinent to epidemiological factors, etiopathogenesis, clinical and histopathologic findings, treatment, and prevention of LLD was collected. 401 records were screened, and 24 unique publications (16 peer-reviewed articles, 1 textbook, and 7 abstracts) were included in the study; 12 (50%), 1 (4%), 6 (25%), and 5 (21%) were classified as evidence level I (experimental), II (quasi-experimental), III (nonexperimental), and V (clinical reports or clinician experience), respectively. Seventeen (71%) and 7 (29%) reports were classified as high quality and good quality, respectively. LLD should be considered a clinical observation indicative of a dermatologic response of fish to suboptimal conditions; LLD should continue to be adopted as the preferred term to describe the classic signs. Whereas gross findings are similar among species, histologic findings can vary. Evidence-based treatment of LLD for individual fish consists of source control (changing tanks or systems), topical treatment with 0.01% becaplermin gel, supportive care, and antimicrobial treatment when warranted. For schools of fish, treatment and prevention of LLD should be focused on improving suboptimal environmental and physiologic conditions.

Platelet-rich plasma injection and becaplermin gel as effective dressing adjuvants for treating chronic nonhealing ulcers in patients with junctional epidermolysis bullosa

Chronic wounds in junctional epidermolysis bullosa (JEB) are associated with significant morbidity and pose a considerable economic burden, especially in resource-limited settings. Because of lack of definitive treatment, advanced silicone foam–based dressings are recommended for wound care, but their scarcity in developing countries leads, instead, to overzealous use of paraffin gauze.1 Platelet-rich plasma is known to benefit chronic ulcers by virtue of various growth and angiogenic factors, and becaplermin is also beneficial in nonhealing ulcers of various etiologies.

Deferoxamine-loaded transfersomes accelerates healing of pressure ulcers in streptozotocin-induced diabetic rats

Diabetic nonhealing ulcers are the leading cause of nontraumatic amputations. An increased cancer risk has been found in patients treated with current therapies such as becaplermin gel. Therefore, an urgent need exists for novel approaches to control delayed ulcer healing. HIF-1α mediates adaptive responses to hypoxia by regulating angiogenesis, proliferation, migration, and cell survival. However, its function is impaired by hyperglycemia. Deferoxamine (DFO) might be an effective HIF-1α stabilizer by inhibiting PHD enzyme through the prevention of iron release in diabetic tissue. Herein, transfersomes were used as nanocarriers for DFO. The system depends on the ability of transfersomes to enhance the penetration of the large hydrophilic drug, DFO through the skin and sustain its release by applying a two-factor, three-level full factorial design to optimize entrapment efficiency, particle size, zeta potential and in vitro drug release. The soybean phosphatidylcholine (SPC) amount and the ratio of surfactant to SPC were selected as independent variables. The formulations had an entrapment efficiency range of 54.46–91.56%, particle size range of 109.2–265.6 nm, polydispersity index values less than one and negative zeta potential range of −17.53 to −29.03 mV. In vitro study revealed that the DFO-loaded transfersomal gel has uniform distribution of DFO, applicable pH, and suitable viscosity and found effective in sustaining DFO release. Moreover, in-vivo study of the optimized formulation demonstrated cutaneous wound healing potential in rats’ diabetic pressure ulcers. Overall, DFO-loaded transfersomal gel shows promise as a potential therapy for the treatment of human diabetic ulcers.

A health needs assessment of adults with diabetic foot disease in the US

IntroductionDiabetic foot disease has been considered as an important complication of diabetes mellitus. The main risk factor to cause diabetic foot disease is peripheral neuropathy. Diabetic foot disease usually started from diabetic foot ulceration, it would develop to diabetic foot infection and amputation even death when conducting the poor prognosis and management of diabetic foot ulceration. Despite this, incidence of diabetic foot disease is still increasing and is therefore potentially under-recognized, under-diagnosed and under-treated all over the word, especially in the US. The aim of this study is to clarify the needs of the adults at risk and health care providers in diagnosis and treatment of diabetic foot disease in the US. MethodsCochrane library, bibliographic databases, American Diabetes Association website and DFS questionnaire website have been used to search the relevant literature of diabetic foot disease among adults in the US. Additionally, conducting subgroup analysis to review the relevant literature. ResultsThe findings of this health needs assessment described that diabetic foot disease in the adults is higher in men than women in the US. American Indian achieved the highest prevalence of diabetic foot disease, in comparison to other ethnic groups. Meanwhile, age has been defined as an important factor to influence the diabetic foot disease rate. Diagnosing properly is important, in accordance with understanding the etiopathogenesis of diabetic foot disease for health professionals. A comprehensive Foot Examination has been established and developed by the American Diabetes Association (ADA). It has been used widely with the characters of easy conducting and rapid performance. Moreover, treatment of DFUs with becaplermin gel obtained the lower cost and the larger clinical benefit when comparing the traditional wound care.

Cost-effectiveness of becaplermin gel on wound healing of diabetic foot ulcers.

We sought to determine the long-term cost effectiveness (payer's perspective) of becaplermin gel plus good wound care (BGWC) vs. good wound care (GWC) alone in terms of wound healing and risk of amputation in patients with diabetic foot ulcers (DFUs). Outcomes data were derived from a propensity score-matched cohort from the Curative Health Services database between 1998 and 2004, which was followed for 20 weeks. A four-state Markov model was used to predict costs and outcomes of wound healing and risk of amputation for BGWC vs. GWC alone over 1 year in patients with DFU. The primary outcome was closed-wound weeks. Transition probabilities for healing and amputation were derived from the aforementioned propensity score-matched cohorts. Ulcer recurrence was estimated from the medical literature. Utilization for becaplermin was calculated using the dosing algorithm in the product labeling. Of 24,898 eligible patients, 9.6% received BGWC. Based on the model, patients treated with BGWC had substantially more closed-wound weeks compared with GWC (16.1 vs. 12.5 weeks, respectively). More patients receiving BGWC had healed wounds at 1 year compared with those receiving GWC (48.1% vs. 38.3%). Risk of amputation was lower in the BGWC cohort (6.8% vs. 9.8%). Expected annual direct costs for DFU were $21,920 for BGWC and $24,640 for GWC. BGWC was economically dominant over GWC, providing better outcomes at a lower cost in patients with DFU. Compared with GWC alone, BGWC is more effective in healing wounds and lowering amputation risk, thereby decreasing long-term costs for DFU.

Safety and efficacy of Becaplermin gel in the treatment of diabetic foot ulcers

Safety and efficacy of Becaplermin gel in the treatment of diabetic foot ulcers

PDB67 - Comparative cost-effectiveness of becaplermin gel on wound healing in patients with diabetic foot ulcer: Changes in wound surface area

Determine the cost-effectiveness of becaplermin gel for the treatment of diabetic foot ulcers (DFU) relative to good wound care (GWC) alone. Wound surface area (WSA) reduction rates were used to predict the expected costs and outcomes of wound healing for becaplermin versus GWC cohorts over a 1-year time horizon. Changes in WSA were taken from the Phase 3 pivotal trials. The outcomes of the analysis include the average percent reduction of baseline WSA, the direct costs of DFU therapy and the cost per centimeter squared of WSA reduction. The costs for becaplermin gel and DFU patient evaluation and management were derived from standard cost references. Becaplermin utilization was calculated using the manufacturer’s recommended dosing algorithm. The economic perspective was that of the payer. Costs are reported in 2013 US dollars. The average WSA at baseline was 2.2 centimeters squared. At 20 weeks in the clinical study the becaplermin group demonstrated a statistically higher probability of complete wound closure compared to the GWC group (p=0.015) at 50% versus 35%, respectively. Given the reported WSA reduction rates, becaplermin treated DFU were expected to close 100% at 27 weeks while the GWC group reached an expected 88% reduction in WSA at 52 weeks. When costs were compared by wound closure rates, the cost per 1 centimeter reduction in WSA was $1,285 in the becaplermin group compared to $3,446 in the GWC group. The total expected direct cost of DFU care across the 1-year time horizon was estimated at $6,702 in the GWC group compared to $2,827 in the becaplermin group. DFU patients treated with becaplermin experienced better clinical outcomes than those treated with GWC alone. As a result of the improved outcomes becaplermin demonstrated economic dominance over GWC providing better outcomes at a lower direct cost.

PDB64 - Comparative cost-effectiveness of becaplermin gel on wound healing and amputation in patients with diabetic foot ulcer

Determine the cost-effectiveness of becaplermin gel* on wound healing and amputation for the treatment of diabetic foot ulcers (DFUs). A 4-stage Markov model was used to predict the expected costs and outcomes of wound healing and amputation rates for becaplermin and non-becaplermin DFU cohorts over a 1-year time period. Outcome data used in the analysis were derived from a propensity score matched cohort of 24,898 subjects with DFU from the Curative Health Services database from 1998-2004 who were followed for 20 weeks. Primary outcomes of interest were ulcer-free weeks and rates of amputation. Costs for amputation and becaplermin gel*were derived from standard cost references and medical supply wholesalers. Total weekly costs per episode of DFU care were estimated from a large retrospective claims database. Transition probabilities for healing and amputation were derived from the aforementioned propensity score matched cohorts. Ulcer recurrence was estimated from the medical literature. Utilization for becaplermin was calculated using the manufacturer’s recommended dosing algorithm. The economic perspective taken was that of the payer. Costs are reported in 2013 US dollars. Overall, 2,394 (9.6%) received becaplermin. Of those who received becaplermin, 33.5% healed at 20 weeks compared to 26.5% who did not receive becaplermin (p<0.0001). In addition, the percent of patients requiring amputation were significantly (p<0.0001) lower in the becaplermin cohort (4.9% versus 6.4%, respectively). Patients treated with becaplermin had substantially higher ulcer-free weeks compared to non-becaplermin patients (16.1 versus 12.5 weeks, respectively). Expected annual direct costs for DFU were $20,885 for becaplermin and $23,506 for non-becaplermin. Becaplermin was economically dominant over standard therapy, providing better outcomes at a lower cost in patients with DFU. In addition, becaplermin is more effective in wound healing and preventing amputation, thereby decreasing long-term costs for DFU. *Regranex®, Smith & Nephew Biotherapeutics, Fort Worth, Texas

PIN59 - Cost-Effectiveness Of Becaplermin Gel On Wound Closure In The Treatment Of Pressure Ulcers

PIN59 - Cost-Effectiveness Of Becaplermin Gel On Wound Closure In The Treatment Of Pressure Ulcers

Commercially Available Topical Platelet-Derived Growth Factor as a Novel Agent to Accelerate Burn-Related Wound Healing

The authors investigated whether the application of platelet-derived growth factor (PDGF) to donor site wounds would speed healing in a porcine model. In a red duroc pig model, three wounds that were 3 inches × 3 inches were created with a dermatome (0.06-inch depth) on one side of two different animals. These wounds were digitally and laser Doppler (LDI) imaged and biopsied immediately pre- and postwound creation and every 2 days for 2 weeks. A set of identical wounds were subsequently created on the opposite side of the same animals and treated with topical PDGF (becaplermin gel 0.01%, 4 g/wound) immediately on wounding. PDGF-treated wounds were imaged and biopsied as above. Digital images of wounds were assessed for epithelialization by clinicians using an ordinal scale. Perfusion units (PU) were evaluated by LDI. Wound healing was evaluated by hematoxylin and eosin histological visualization of an epithelium and intact basement membrane. First evidence of partial epithelialization was seen in control and PDGF-treated wounds within 7.7 ± 1.4 and 6.4 ± 1.1 days postwounding, respectively (P=.03). Completely epithelialized biopsies were seen in control and PDGF-treated wounds at 11.7 ± 2.6 and 9.6 ± 1.5 days, respectively (P=.02). Clinician evaluation of digital images showed that on day 9, control wounds were, on average, 48.3 ± 18.5% epithelialized vs 57.2 ± 20.2% epithelialized for PDGF-treated wounds. At day 16, control wounds showed an average of 72.9 ± 14.6% epithelialization and PDGF-treated wounds showed an average of 90 ± 11.8%epithelialization. Overall, PDGF-treated wounds had statistically significantly higher scores across all timepoints (P=.02). Average perfusion units as measured by LDI were similar for control and PDGF-treated wounds at time of excision (225 ± 81and 257 ± 100, respectively). On day 2 postwounding, average PU for control wounds were 803 and were 764 for PDGF-treated wounds. Control wounds maintained higher PU values compared with PDGF-treated wounds at all time points and returned to excision PU values by day 12.2 ± 1.1 postwounding. PDGF-treated wounds reached the same values by day 9.7 ± 2.3 (P=.03). The authors conclude that topical PDGF speeds time to epithelialization of partial-thickness wounds in a porcine model as evidenced by histology, clinical appearance, and time to return to prewounding vascularity.

Angiodermites nécrotiques : caractéristiques épidémiologiques et facteurs pronostiques de cicatrisation dans une cohorte prospective

The data concerning changes in the characteristics of hypertensive leg ulcers (HLU) were taken from open studies in a small patient cohort. The aim of this study was to describe the epidemiological characteristics and to identify prognostic factors for healing in a prospective cohort of 59 patients presenting HLU. The cohort comprised patients included in a randomized, double-blind, controlled study published elsewhere; the patients were receiving becaplermin gel (Regranex(®)) or Duoderm Hydrogel™ once daily for eight weeks for the most recent wound. Total follow-up was 12 weeks. The epidemiological analysis was performed for 59 consecutive patients randomized in 17 dermatology departments. Mean patient age was 74.5 ± 9 years and 61% were female. Mean wound duration was 11.1 ± 9 weeks and median wound area was 16 cm(2) (q1; q3: 8; 25.5). Among, 94.9% of patients had hypertension and 39.7% were diabetic. A homolateral peripheral pulse was present in 91.5% of patients. At the end of follow-up, complete wound healing was obtained in 30.5% of the patients. In univariate analysis, neither the foregoing criteria nor the treatment group were significantly associated with healing during the study. This study confirms female predominance, old age, prevalence of diabetes and delay in the diagnosis of HLU. The prognosis for healing does not appear to be dependent on wound duration, wound area or the presence of moderate peripheral arterial disease, doubtless because this condition progresses by episodes of flare-up and under specific conditions.

Topical Treatment of Hypertensive Leg Ulcers With Platelet-Derived Growth Factor-BB

To determine the healing effect of topical becaplermin gel vs hydrogel dressing on hypertensive leg ulcers. Randomized, double-blind, parallel-assignment, controlled study. Ambulatory or hospitalized patients from 17 dermatology departments. Among 64 consecutive randomized patients with 1 or more hypertensive leg ulcers who fulfilled all inclusion criteria, 59 received the allocated intervention, and findings were analyzed. Becaplermin gel (human recombinant platelet-derived growth factor-BB, 0.1%, in hydrogel) or hydrogel dressing was applied, both in doses of 1 cm/cm(2), once daily for 8 weeks. Follow-up continued for 4 weeks beyond the final gel application. The primary end point was complete wound closure rate after 8 weeks of treatment. Secondary end points were percentages of patients with complete wound closure at week 12; changed ulcer area after treatment vs baseline; and changed ulcer-related pain and health-related quality of life during the study. Complete wound closure rates were comparable after 8 weeks for becaplermin (5 of 28 patients) and hydrogel (3 of 31 patients) (8 percentage-point difference; 95% confidence interval, -10% to 26%). No statistically significant differences were observed between the 2 groups for percentages of complete closure at week 12, changed ulcer area at week 8, or changed ulcer-related pain and quality of life during the study (P > .05 for all comparisons). Topical becaplermin gel is not superior to hydrogel dressing for hypertensive leg ulcer wound closure. Surgical management by grafting remains the most promising treatment strategy but requires further evaluation. Trial Registration clinicaltrials.gov Identifier: NCT00970697.

Off-Label Use of Becaplermin Gel (Recombinant Platelet-Derived Growth Factor-BB) for Treatment of Mucosal Defects After Corticocancellous Bone Graft: Report of 2 Cases With Review of the Literature

Wound healing is characterized by acute inflammation, granulation tissue formation, and scar tissue formed by remodeling. The process of wound repair during injury, whether traumatic or surgical, is paramount to human survival. Platelet-derived growth factor (PDGF) is considered one of the principal growth factors appearing on the wound surface. Growing evidence has shown that PDGF contributes to wound repair by attracting and stimulating the proliferation of wound-healing cells. In vitro studies have indicated that PDGF is chemotactic for neutrophils, monocytes, and fibroblasts.

Becaplermin gel in the treatment of diabetic neuropathic foot ulcers.

Diabetic foot ulcers remain a major cause of morbidity. Significant progress has been accomplished in ulcer healing by improved management of both ischemia and neuropathy in the diabetic foot. Nevertheless, there is a vital need for further improvement. Becaplermin gel represents an important therapeutic advance for diabetic neuropathic foot ulcers with adequate blood supply. Randomized controlled trials have shown that it is effective in increasing healing rates. However, this efficacy has not translated to positive clinical experience, and the drug is not widely used. Moreover, becaplermin is an expensive medication. Even though it has repeatedly been estimated as cost-effective, its high cost may be prohibitive for some clinicians, especially in developing countries. Clearly, further work is needed to clarify whether use of becaplermin is justified in everyday clinical practice. Future research also needs to assess the potential room for improvement with becaplermin, for instance by combination with other growth factors or by exploring alternative modes of drug delivery.

A review of becaplermin gel in the treatment of diabetic neuropathic foot ulcers

Diabetic neuropathic foot ulcers represent a serious health care burden to patients and to society. While the management of chronic diabetic foot ulcers has improved in recent years, it remains a frustrating problem for a variety of clinicians. This review examines the scientific underpinnings supporting the use of becaplermin (Regranex((R)); Ortho-McNeil Pharmaceutical, Raritan, NJ), or recombinant human platelet-derived growth factor (rhPDGF-BB), in diabetic forefoot wounds. An emphasis is placed upon proper medical and surgical care of diabetic foot wounds, as multiple studies have demonstrated that the success of this growth factor in accelerating healing is ultimately dependent on proper ulcer care. A focus on the cost-effectiveness of this form of therapy in the treatment of diabetic foot ulcers is also outlined.

Granulocyte–Macrophage Colony-Stimulating Factor Is Essential for Normal Wound Healing

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a multipotent growth factor, which plays an important role during the process of wound healing. In clinical settings it has occasionally been employed in the treatment of cutaneous wounds of diverse etiologies. In a previous study, we have shown the positive influence of GM-CSF on full thickness excisional wounds in transgenic mice overexpressing GM-CSF in the basal layer of the epidermis. Direct GM-CSF action as well as indirect processes through the induction of secondary cytokines were proposed to contribute towards the beneficial effects. In this study, we analyzed the process of wound healing in transgenic mice overexpressing a GM-CSF antagonist in the epidermis. These mice not only exhibited a delayed scab rejection and reepithelialization but also neovascularization was reduced. The newly formed tissue was of poor quality as exhibited by the presence of extensive fibrosis. We suggest that the presence of GM-CSF in the repair process is of basic importance and its absence leads not only to delayed wound healing but it is also detrimental for the quality of the newly formed tissue.

Accelerated Healing of Excisional Skin Wounds by PL 14736 in Alloxan-Hyperglycemic Rats1

PL 14736 is a synthetic peptide, originally isolated from human gastric juice, that has anti-inflammatory and tissue-protective actions in experimental models of gastrointestinal inflammation. To investigate its possible benefit in poorly healing skin wounds, the effects of the topical application of PL 14736 in a gel formulation have been studied on full-thickness excisional wounds in rats, either healthy or made hyperglycemic by alloxan (175 mg/kg s.c.) 5 days previously. The effects of becaplermin gel (platelet-derived growth factor, PDGF-BB, Regranex^®), a standard therapy for diabetic foot ulcers, were investigated for comparison. Healing was evaluated for up to 7 days after wounding, using digital planimetry analysis, macroscopic scoring and histology. While healing was too rapid in healthy rats to observe enhancement by either treatment, in the hyperglycemic rats which exhibited delayed healing, PL 14736 (10–1,000 µg/wound) produced a dose-dependent acceleration of wound healing (determined by macroscopic scoring) equivalent at the highest doses to that observed with becaplermin. The beneficial effect on healing was associated with increased deposition of organized granulation tissue by day 7 for both PL 14736 and becaplermin, as determined histologically. PL 14736 tended to have a greater effect than becaplermin on the formation of granulation tissue containing mature collagen. Wound contraction, as measured by planimetry, was not significantly affected. In conclusion, topical PL 14736 produces a dose-dependent acceleration of deficient skin wound healing in hyperglycemic rats by facilitating granulation tissue formation, similar to the response seen with topical becaplermin, the standard therapy for diabetic skin wounds. PL 14736 may represent an alternative therapy for delayed wound healing, such as that seen with diabetic foot ulcers, without the proliferative concerns or immunogenicity associated with growth factors.

Outcomes of Conventional Wound Treatment in a Comprehensive Wound Center

Conventional wound care is the elementary treatment modality for treating chronic wounds. However, early treatment with topical growth factors may be needed for a subset of chronic wounds that fail to heal with good wound care alone. A prospective nonrandomized case series from a single-community outpatient wound care clinic is presented here in an effort to identify the subset of chronic wounds that may require early adjuvant intervention. There were 378 consecutive patients with 774 chronic wounds of varying etiology. All patients received 4 weeks of conventional wound care, including weekly debridement and twice-daily dressing changes. Wounds not reduced by 50 per cent volume at 4 weeks were nonrandomly treated with human skin equivalent (Apligraf), platelet-derived wound healing factor, or platelet-derived growth factor isoform BB (becaplermin gel, Regranex). A total of 601 of 774 (78%) wounds healed regardless of treatment type. The median time to heal for all wounds was 49 days (interquartile range = 26-93). More women than men healed (85% vs 71%, respectively, P < 0.0001). Diabetic wounds were as likely to heal as nondiabetic wounds (78% vs 80%, P = 0.5675). Wounds that did not heal had larger volumes and higher grade compared with wounds that healed (P < 0.0001 for both variables). The data presented here show that the majority of chronic wounds will heal with conventional wound care, regardless of etiology. Large wounds with higher grades are less responsive to conventional wound care and will benefit from topical growth factor treatment early in the treatment course.