Reduction In Ulcer Area Research Articles

A COMPARATIVE STUDY BETWEEN THE EFFECTIVENESS OF AUTOLOGOUS PLATELET-RICH FIBRIN VERSUS SALINE DRESSING IN THE MANAGEMENT OF CHRONIC VENOUS LEG ULCERS

Background: Venous disease is responsible for around 85% of all chronic lower limb ulcers in resource-rich countries. Venous leg ulcer is a chronic condition, and various treatment modalities are available. Various adjunctive wound care therapies and procedures are available that can be utilized as part of a comprehensive approach to healing venous stasis ulcers. Platelet-rich brin (PRF) is one of the newer modalities and it contains broblast growth factor (FGF), VEGF, angiopoietin and platelet-derived GF which enhances the wound healing. We conducted a randomized controlled trial to compare the efcacy of PRF versus saline dressing in chronic venous leg ulcers. Aim: To compare the efcacy of autologous PRF with saline dressing in patients with chronic venous leg ulcer in terms of mean reduction in ulcer area, presence of infection and cosmetic outcome at the end of 4 weeks. Materials and Methods: Thirty patients with chronic venous leg ulcers of >6 months duration having an ulcer area of 1 cm × 1 cm to 5 cm × 5 cm were taken into the study and were randomly divided into two groups. Group 1: Patients received PRF dressing. 10 mL of patient's blood was taken and centrifuged at 3000 rpm for 15 min. A brin clot obtained in the middle of the tube was removed and used for dressing over the wound surface. It was repeated every week for 4 weeks. Group 2: Patients received saline dressings once a week for 4 weeks. The assessment of the ulcer size was done with the help of photographs, and ulcer area was measured. Results: The mean reduction in the area of the ulcer size in PRF group was 81.84%, and the mean reduction in the area of the ulcer size in Saline group was 59.84%. Conclusion: Platelet rich brin matrix is a novel modality and an ideal, safe, affordable therapeutic option for chronic venous leg ulcers.

Effect of topical phenytoin with normal saline dressing in patients of diabetic foot ulcers

Background: The management of wound and wound dressing is an important aspect of chronic ulcer management. Choosing an appropriate dressing can be a complex process. Topical phenytoin helps in faster wound remodelling. The objective of the study was to assess the effect of topical phenytoin dressing with normal saline dressing in healing of diabetic foot ulcer in terms of mean decrease in size of the ulcer.Methods: The present study was conducted on 60 patients with diabetic foot ulcer. The patients were divided into two different groups (group 1 topical phenytoin and group 2 normal saline dressing). Wound measurement was taken on day one and end of every week for four weeks. Mean reduction in ulcer area at the end of four weeks was calculated.Results: There was no statistical difference in the baseline characteristics like age, sex and initial wound area of the ulcer between the two groups. The mean reduction in wound area was 1856.9±724.9 mm2 in patients treated with topical phenytoin dressings and 1066.8±565.3 mm2 in patients treated with normal saline dressings, which is statically significant (p<0.001).Conclusions: The study concluded that the topical phenytoin dressing can be used for the healing of diabetic foot ulcer.

Evaluation of timolol maleate gel for management of hard-to-heal chronic venous leg ulcers. Phase II randomised-controlled study

BackgroundVenous leg ulcers (VLUs) often take a very long time to heal. Timolol maleate has been reported as displaying efficacy in healing of VLUs. ObjectivesTo evaluate the efficacy of timolol maleate gel in the management of hard-to-heal VLUs and to assess its safety as a topical agent during 12 weeks of use in combination with conventional treatment. MethodsA prospective, phase-II randomised-controlled trial with a sample size based on Fleming's one-stage design (P0=0.25, P1=0.45, alpha=0.1, beta=0.2) was planned. Patients with VLUs present for ≥24 weeks and with ≥50% granulation tissue were included. One drop of sustained-release timolol gel (Timoptol® LP 0.5%, Santen, Tampere, Finland) per 6 cm2 VLU area was applied every 2 days for 12 weeks in timolol-treated patients, as adjuvant therapy to the standard care protocol (interface dressing and multilayer venous compression). Controls received standard care alone. The primary endpoint was to obtain ≥40% reduction in ulcer area at week 12 (W12). ResultsForty-three patients were randomised to the study, with 40 receiving at least one treatment and included in the analysis: 21 timolol-treated patients and 19 controls (females: 70%; median age: 72.5 [range 35–93] years). At W12, ≥40% ulcer-area reduction was achieved in 14/21 (67%) timolol-treated patients vs. 6/19 (32%) controls. No serious adverse events occurred. Local wound infections not requiring systemic antibiotics occurred in 5 cases in the timolol group and in one case in the controls. ConclusionsThese results support the benefit and safety of using timolol maleate to manage hard-to-heal VLUs, but confirmation is required in a larger multicentre randomised phase-III study.

Quality of reporting of outcomes in trials of therapeutic interventions for pressure injuries in adults: a systematic methodological survey.

Randomised controlled trials of therapeutic interventions for pressure injuries should include a clear description of outcomes to increase transparency and replicability and improve the construction of scientific evidence. The objective of this study was to assess the completeness of the descriptions of the outcomes of therapeutic interventions in adults with pressure injury (PI) and factors associated with completeness. This was a systematic methodological survey. The completeness of the outcome was assessed according to five criteria: domain (title), specific measure (technique/instrument used), specific metric, or format of the outcome data of each participant that was used for analysis, aggregation (method data from each group were summarised), and time that was used for analysis. Sixty‐eight studies were included for analysis. A total of 265 outcomes were reported, and 46 trials (67.6%) had 73 primary outcomes, which were mainly intermediates/substitutes (78.8%). The main outcome evaluated was the ulcer area reduction (36.6%). Approximately 37.2% of the outcomes were incompletely reported, and the least described element was the data aggregation method (72.8%). Only 48.4% of the outcomes with the specified technique had the same reference or validation. Poor quality of reporting outcomes was associated with studies with an older year of publication and a small sample size, single‐center studies, and those sponsored by industry. PI studies use many outcomes, mostly surrogates or intermediates, and some of them are incompletely described.

Metatarsal Head Resection Versus a Removable Mechanical Device for Offloading of the Neuropathic Diabetic Plantar Forefoot Ulcer.

Although surgical offloading seems a more permanent solution for prevention and treatment of neuropathic plantar diabetic forefoot ulcers (DFUs), the evidence for this assumption is weak and needs further studies to be established. The aim of this retrospective study is to compare the healing efficacy, associated morbidity, and recurrence rates of surgical versus removable knee-high offloading for neuropathic plantar (DFUs) healing. From January 2016 to January 2018, 70 neuropathic plantar forefoot DFUs were nonrandomly assigned to either removable knee-high cam-walker (n = 35), or metatarsal head, or accessory bone resection (n = 35). The primary endpoints were the frequency and rate of complete healing, and the rate of ulcer area reduction within 4 months. The secondary endpoints were 4 months morbidity and ulcer recurrence within 12 months. After 4 months, complete healing was significantly inferior with cam-walker compared with surgical offloading; 24 (67.6%) versus 31 patients (88.6%), respectively, P = .015. Ulcer area reduction was 2.4 cm2 (66.7%) versus 2.6 cm2 (83.9%), P = .001, in the mechanical versus the surgical groups, respectively. The mean healing time was 3.6 ± 2.1 versus 2.8 ± 0.6 months in the mechanical versus the surgical groups, respectively, P = .012. Morbidity and recurrence show nonsignificant differences between both groups. Ulcer recurrence was noted in 5/35 (14.3%) versus 2/35 (5.7%), in mechanical versus surgical groups, respectively, P = .23. Therefore, metatarsal head/accessory bone resection offered improved healing efficacy but similar morbidity and recurrence to the removable cam-walker.

Efficacy of Intralesional Platelet-Rich Plasma in Diabetic Foot Ulcer.

Diabetic foot ulcer (DFU) is well managed by infection control, euglycemic state, and debridement of the ulcer followed by appropriate dressing and off-loading of the foot. Studies show that approximately 90% of DFUs that are properly off-loaded heal in nearly 6 weeks. Platelet-rich plasma (PRP) serves as a growth factor agonist and has mitogenic and chemotactic properties that help in DFU healing. We sought to evaluate the efficacy of local application of PRP with respect to healing rate and ulcer area reduction in treating DFUs. Sixty noninfected patients with DFUs (plantar surface area, ≤20 cm2; Meggitt-Wagner grades 1 and 2) were randomized to receive normal saline dressing (control group [CG]) or PRP dressing (study group [SG]) along with total-contact casting for 6 weeks or until complete ulcer healing, whichever was earlier. Healing rate and change in ulcer area were evaluated weekly. Mean ± SD ulcer area at baseline was 4.96 ± 2.89 cm2 (CG) and 5.22 ± 3.82 cm2 (SG) (P = .77), decreasing to 1.15 ± 1.35 cm2 (CG) and 0.96 ± 1.53 cm2 (SG) (P = .432) at 6 weeks. Mean ± SD percentage reduction in healing area at 6 weeks was 81.72% ± 17.2% (CG) and 85.98% ± 13.42% (SG) (P = .29). Mean ± SD healing rate at 6 weeks was 0.64 ± 0.36 cm2 (CG) and 0.71 ± 0.46 cm2 (SG) (P = .734). The PRP dressing is no more efficacious than normal saline dressing in the management of DFU in conjunction with total-contact casting.

自己表皮由来細胞シート（ジェイスⓇ）植皮で良好な潰瘍面積の縮小を得た，中等症型劣性栄養障害型表皮水疱症の2例

自己表皮由来細胞シート（ジェイスⓇ）植皮で良好な潰瘍面積の縮小を得た，中等症型劣性栄養障害型表皮水疱症の2例

A pilot feasibility study of non-cultured autologous skin cell suspension for healing diabetic foot ulcers.

A prospective, single arm feasibility study was conducted to evaluate healing outcomes of DFUs treated with autologous skin cell suspension (ASCS) in combination with standard therapy. Wounds up to 100 cm2 in size that failed to heal with conventional therapy were included and wound healing, pain, exudate scores, Quality of Life, satisfaction scores, and safety outcomes were evaluated over a period of 26 weeks. Sixteen subjects were enrolled having a mean DFU duration of 60.4 weeks. All ulcers in this study had a positive healing trajectory, with a mean reepithelialization of 84.9% and 12.2 cm2 reduction in ulcer area. For ulcers that did not acquire a soft tissue infection post-treatment, all either healed or achieved ≥95% reepithelialization including some with exposed tendon. Improvements were observed in all aspects of the health-related Quality of Life questionnaire and subjects and clinicians were highly satisfied across all postoperative visits. This preliminary study suggests ASCS is a well-tolerated and promising therapy for the treatment of DFUs as all ulcers evaluated experienced positive healing results regardless of size, depth, and wound duration. Future studies are warranted to investigate ASCS compared to standard of care for all diabetic foot ulcers, inclusive of the evaluation of treatment algorithms and combination products.

Estimation of percent wound area reduction over a period of four weeks among diabetic foot ulcers

Foot ulcers are the most commonly experienced,fearful complications of diabetes which can frequently be life or limb-threatening.Several factors can lead to the occurrence of foot ulcers in diabetics.Prevention and proper management of DFUs are the prime most important in the care of patients with diabetes. It is essential to predictthe wound healingtime in managing the diabetic foot ulcers.The main objective of the study is to examine the reduction in wound area over four weeks in achieving more than 50 % Percentage Area Reduction (PAR) as a clinical outcome.Twowound irrigation methods were used for irrigating the wounds. Assessment of the wound area was done and comparedon achieving more than 50 % reduction in ulcer area at the end of four weeks. The studyused a descriptive comparative design with a control group. DiabeticFoot ulcerpatients (N = 160) from a private hospital were randomly allocated into 80 in each group (Neem solutionirrigation and Normal saline irrigation groups). In both groupsSurface area of the wound was measured using a disposable wound ruler with standard calibrations at baseline and then at the end of each week till four weeks are completed. Data were analyzed in SPSS20 software while considering p< .05 as statistically significant.The mean Wound surface area of the Normal saline group was 18.41 at the end of the first week and 14.04 after four weeks verses 19.84. The above-quoted scores in the Neem solution irrigation group were 14.68 and 6.92, respectively, against 17.13(p < .05).At the end of 4 weeks, the mean per cent reduction in area from baseline of DFUs irrigated with Neem solution was 72.4 % and with Normal saline was 48.7 %. Ulcers irrigated with neem solution had a 28.7 % greater mean reduction in area from baseline when compared with the normal saline control group at the end four weeks (p<.05).

Protective Mechanism of Acacia saligna Butanol Extract and Its Nano-Formulations against Ulcerative Colitis in Rats as Revealed via Biochemical and Metabolomic Assays.

Ulcerative colitis (UC) is a relapsing inflammatory disease of unknown etiology. The increased risk of cancer in UC patients warrants for the development of novel drug treatments. Herein, this work concerns with the investigation of the protective effects of Acacia saligna butanol extract (ASBE) and its nanoformulations on UC in a rat model and its underlying mechanism. Colitis was induced by slow intrarectal infusion of 2 mL of 4% (v/v in 0.9% saline) acetic acid. Colon samples were evaluated macroscopically, microscopically, and assayed for pro-inflammatory cytokine levels. To monitor associated metabolic changes in acetic acid-induced UC model, serum samples were analyzed for primary metabolites using GC–MS followed by multivariate data analyses. Treatment with ASBE attenuated acetic acid-induced UC as revealed by reduction of colon weight, ulcer area, and ulcer index. ASBE treatment also reduced Cyclooxygenase-2 (COX-2), Prostaglandin E2 (PGE2) & Interleukin-1β (IL-1β) levels in the inflamed colon. The nano-formulation of ASBE showed better protection than the crude extract against ulcer indices, increased PGE2 production, and histopathological alterations such as intestinal mucosal lesions and inflammatory infiltration. Distinct metabolite changes were recorded in colitis rats including a decrease in oleamide and arachidonic acid along with increased levels of lactic acid, fructose, and pyroglutamic acid. Treatment with nano extract restored metabolite levels to normal and suggests that cytokine levels were regulated by nano extract in UC. Conclusion: ASBE nano extract mitigated against acetic acid-induced colitis in rats, and the underlying mechanism could be attributed to the modulatory effects of ASBE on the inflammatory cascades. The applicability of metabolomics developed in this rat model seems to be crucial for evaluating the anti-inflammatory mechanisms of new therapeutics for acute colitis.

Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial

IntroductionDiabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of...

Comparative analysis of conventional dressing vs. topical heparin dressing in lower limb diabetic ulcers

Background and Aim: Lower limb diabetic ulcers are very difficult to treat due to the poor vascularity and brittle granulation tissue formed during the healing phase. So a novel method is needed apart from conventional dressings to enhance the healing process. Objectives of current study were to estimate the length of hospital stay and antibiotic requirement among patients with lower limb diabetic foot ulcers, to estimate the length of hospital stay and antibiotic requirement among patients with diabetic foot ulcers managed with Heparin dressing and to compare the effect of topical heparin dressing over conventional dressing in diabetic foot ulcers. Material and Methods: A cross-sectional comparative study was done among patients diagnosed with diabetic foot ulcers admitted in the surgical ward of a teaching institution of Tertiary care hospital India. Total of 200 patients were included in the study and were divided in to two study groups, for Group 1 only conventional dressing was done, for Group 2 topical heparin solution was applied, for both groups glycemic control and antiboitics were added accordingly and monitored. Results: Majority (80%) of the study participants were male of which 46.25% of the received heparin treatment. The mean hospital stay was higher in conventional group compared to Heparin group. Of the total study participants, majority (75%) received empirical sensitive antibiotics while only 25% had the drug revised by culture and sensitivity, of which majority 36 (72%) belonged to the conventional group of treatment. Conclusion: The group having the application of heparin dressing showed significantly better granulation tissue development, faster reduction of ulcer area and shorter duration of hospitals stay, as compared to conventional dressing using povidone iodine.

A topical cell therapy approach for diabetic chronic ulcers: Effects of mesenchymal stromal cells associated with platelet-rich plasma.

Diabetic cutaneous ulcers are subjected to several physiological and biochemical defects, which contribute to wound chronicity and therapeutic failure. Platelet-rich plasma (PRP) has been used for stimulating tissue regeneration, and mesenchymal stromal cells (MSCs) have demonstrated therapeutic properties in all phases of skin regeneration in cell therapy studies. The objective of this study was to evaluate the therapeutic effects related to the use of a biomembrane composed of autologous MSCs and PRP on chronic wounds of diabetic patients (pre-post pilot study). Six diabetic patients with chronic wounds for more than 6months were subjected to adipose tissue collection for isolation of MSCs, blood collection for PRP preparation, and topical administration of a biomembrane of MSCs and PRP on each chronic wound. The statistical difference regarding the evolution of ulcers was calculated by means of paired t test. There was granulation tissue formation starting from 7days after topical application. Total re-epithelialization occurred in 5 of the 9 lesions treated, and the mean wound healing rate (WHR) was 74.55% (±32.55%) after 90days. No cicatricial hypertrophy or retraction was observed. Mesenchymal stromal cells topical therapy associated with PRP is well-tolerated and able to provide a reduction in ulcer area of diabetic chronic wounds.

Plasma rico em plaquetas no tratamento de úlceras venosas: série de casos

Objetivo: Avaliar a viabilidade do tratamento de úlceras venosas com o Plasma Rico em Plaquetas (PRP). Método: Estudo descritivo do tipo série de casos, realizado como piloto de um ensaio clínico, com amostra de três pacientes, alocados após a randomização, dois para intervenção e um para o controle. O custo direto foi coletado por meio de observação direta. Resultados: Nos pacientes que receberam a intervenção (PRP), das duas úlceras venosas acompanhadas, uma apresentou cicatrização total, com um custo de US$550,35 e a outra obteve taxa de redução de área de 33,33%, com o custo de US$1.070,32. No paciente controle, a taxa de redução da úlcera venosa foi de 83,33%, com o custo de US$361,53. Discussão: A partir do teste piloto, foi possível adequar os protocolos e determinar os insumos para realização do estudo. Conclusão: A avaliação de protocolos clínicos é de suma importância para o desenvolvimento de ensaios clínicos controlados.

Effect of Olive Oil in Preventing the Development of Pressure Ulcer Grade One in Intensive Care Unit Patients.

Background:Detecting pressure ulcer is an important nursing diagnostic care required for the patients hospitalized in ICU. The purpose of this study is to examine the effect of olive oil in preventing the development of pressure ulcer grade one in ICU patients.Methods:In this clinical trial, 72 patients eligible for hospitalization in hospitals of Isfahan University of Medical Sciences were divided randomly into two groups; control and intervention (receiving olive oil). The standard program of skincare was implemented on both the groups; in addition, olive oil was applied topically in the intervention group. The data was collected on the first day through demographic information and Braden pressure ulcer risk assessment scale. An infrared thermometer was used to record the local temperature of the ulcers daily. Assessments were made based on pressure ulcer scale for healing (PUSH) tool and the pressure ulcer area was examined per square cm on the first, fourth, and seventh day. The data collected was analyzed by Fisher's exact test, independent sample t-test and repeated measure analysis using SPSS (version 22).Results:On the fourth and seventh day, the PUSH score was lower in the olive oil group (7.50 ± 2.823 and 5.44 ± 3.806) than in the control group (9.50 ± 1.732 and 8.83 ± 2.864) (P-value <0.001). Also, a significant improvement of ulcer was observed in the olive oil group (mean difference = 3.56; P value <0.001) but no change was observed in the control group (mean difference = 0.75; P value = 0.052).Conclusions:Based on the effect of olive oil in the reduction of ulcer area and the average PUSH score obtained in ICU patients, the application of olive oil is recommended for healing grade one pressure ulcers.

Comparison of Efficacy of Autologous Platelet-Rich Fibrin versus Unna's Paste Dressing in Chronic Venous Leg Ulcers: A Comparative Study.

Background:Chronic venous leg ulcers are difficult to treat and recurrences are common. Among various modalities of treatment, platelet-rich fibrin (PRF) has shown promising results in ulcer healing by providing necessary growth factors. Unna's paste dressing has also proven to enhance wound healing.Aim:The aim of this study is to compare the efficacy of autologous PRF versus Unna's paste dressing in chronic venous leg ulcer patients and to compare the mean reduction in ulcer area at the end of 4 weeks.Materials and Methods:Twenty patients with chronic venous leg ulcers were randomly divided into two groups. Group 1: Patients received PRF dressing which was repeated every week for 4 weeks. Group 2: Patients received Unna's paste dressing once a week for 4 weeks. The ulcer size was assessed with the help of photographs, and ulcer area was measured.Results:The mean reduction in the area of the ulcer size in the PRF group was 86.03% and in the Unna's paste group was 71.97%, which was not statistically significant with a P value of 0.223.Conclusion:We conclude that though there was no statistical significance between the groups, PRF showed a significant reduction in ulcer size.

Efficacy of Topical Timolol versus Saline in Chronic Venous Ulcers: A Randomized Controlled Trial.

Background:Chronic venous ulcers sometimes fail to heal in spite of adequate treatment. Nonhealing is possibly because of chronic activation of β-2 adrenergic receptor (B2-AR) in the keratinocytes by endogenously generated catecholamines, which inhibits keratinocyte migration. Blocking of B2-AR using β-blockers has been reported to promote wound healing through keratinocyte migration, angiogenesis, and fibroblast migration. Topical timolol, a B2-AR antagonist, is used to promote wound healing.Aims and Objectives:The aim of this study was to compare the efficacy of topical timolol versus saline in chronic venous leg ulcers and to compare the mean reduction in ulcer area at the end of 4 weeks.Materials and Methods:Twenty patients were randomized into two groups. Patients in Group 1 were treated with one drop of 0.5% topical timolol every alternate days for 4 weeks. Ulcer margins were measured and ulcer area calculated every week for 4 weeks. Similar dressing and measurement were carried out for patients with saline for 4 weeks. Healing rate was assessed by the percentage of reduction of ulcer area of both groups at week 4.Results:The mean reduction in the ulcer size in timolol group was 86.80%, and in saline group 43.82% at the end of 4 weeks.Conclusion:Topical timolol is an easy, noninvasive therapy that can be recommended for chronic ulcer.

Comparison of octenidine wound gel versus povidone-iodine dressing in healing of chronic diabetic foot ulcers: A randomized controlled trial for period of 1 year

Context: Octenidine is an antiseptic known for the past 20 years. Very few clinical studies have been done in evaluating the advantages of octenidine. Specific characters of no anti microbial resistance, good host tissue tolerability and very few clinical studies made us to conduct this study. Aims: To compare octenidine wound gel dressing versus povidone-iodine (PVI) dressing in healing of chronic diabetic foot ulcers (DFUs) in terms of mean percentage reduction in the ulcer area. Settings and Design: A randomized controlled study was conducted at a tertiary care hospital in North Karnataka between January 2018 and December 2018. Subjects and Methods: Eighty cases of chronic DFU were selected and randomized (sequentially numbered, opaque-sealed envelopes technique) into two groups – Group A: octenidine dressing done and Group B: PVI dressing done for 14 days. The wound healing was calculated as the mean percentage reduction in the ulcer area. The wound healing was then compared between two groups. Statistical Analysis Used: Student's unpaired t-test and Chi-square test were used for analysis. Results: Ulcer healing was early in Group A compared to Group B; the mean percentage reduction in the ulcer area was 25.51 ± 9.26 and 14.48 ± 6.54 sq.cm in Group A and Group B, respectively (P Conclusions: Octenidine wound gel has shown good progress of ulcer healing in terms of ulcer area reduction compared to PVI dressing.

Evaluation of Wound Closure Rates Using a Human Fibroblast-derived Dermal Substitute Versus a Fetal Bovine Collagen Dressing: A Retrospective Study

A retrospective study was conducted to evaluate the proportion of patients healed and time to healing of DFUs treated with a human fibroblast-derived dermal substitute (HFDS) or a fetal bovine collagen dressing (FBCD). Data from patients with a DFU who received the first treatment in 2014 were extracted from the electronic record database of 93 wound care centers. Baseline demographics (eg, age, gender, body mass index, and number of wounds); wound location, size, and duration; and wound-specific information such as wound size and number of and interval between applications were obtained. Study criteria stipulated patients who received at least one treatment in 2014 with HFDS or FBCD on a DFU with location coded as foot, toe, heel, metatarsal head, toe web space, toe amputation site, or transmetatarsal amputation site; ulcer size ≥1 cm2 to <20 cm2; and ulcer area reduction ≤50% in the 28 days before the first treatment with HFDS or FBCD were eligible for inclusion. Wounds that received an alternate skin substitute treatment up to 28 days before or concurrent with the first HFDS or FBCD treatment or if patient data that lacked baseline or follow-up wound area measurement were excluded. Deidentified data were extracted directly into data files and transferred to a third-party data management and statistical group for analysis. The frequency of DFUs achieving wound closure (defined as area ≤0.25 cm2) by weeks 12 and 24 and median time to wound closure of wounds that healed were analyzed. Baseline characteristics were compared using 2-sample t tests for continuous variables and 2-tailed Fisher's exact tests for difference in proportions between treatments. Frequency of and median time to wound closure were determined by Cox proportional hazards analysis. The frequency of wounds closed at 12 and 24 weeks, median time to wound closure, hazard ratio with 95% confidence interval, and P value were estimated from the Cox model. Statistical significance was defined as P <.05. Records showed 206 patients with 208 DFUs received treatment (108 HFDS, mean age 60.2 years, mean wound duration 8.8 months; 100 FBCD, mean age 65.2 years, mean wound duration 12.8 months) and were included. Mean number of treatment applications was 4.5 and 2.4 for HFDS and FBCD, respectively. After 12 and 24 weeks 44 (41%) and 69 (64%) of HFDS-treated wounds, respectively, and 21 (21%) and 43 (43%) of FBCD-treated wounds, respectively, were healed (at 12 weeks, P = .03; at 24 weeks, P = .03, log rank 2-tailed test, unadjusted). Median time to wound closure for HFDS and FBCD was 14.6 and 25 weeks, respectively (P = .03; log rank, 2-tailed test; Kaplan-Meier analysis). HFDS treatment significantly increased the probability of wound healing compared to FBCD treatment in the Cox proportional hazards analysis after adjusting for treatment terms, baseline wound area, baseline wound duration, baseline wound depth, wound location, and patient age at first treatment (HR = 1.77; 95% CI: 1.06-2.97; P = .03). DFU wounds are more likely to heal when treated with HFDS than with FBCD as used by facilities in this database. Studies examining the efficacy, cost-effectiveness, and patient-centered outcomes of these treatments is warranted. .

Interventions for ulceration and other skin changes caused by nerve damage in leprosy.

Interventions for ulceration and other skin changes caused by nerve damage in leprosy.