Painful Leg Ulcers Research Articles

Paediatric pyoderma gangrenosum treated with ustekinumab

AbstractPyoderma gangrenosum (PG) is a rare reactive noninfectious inflammatory dermatosis. More than 50% of PG patients have an associated systemic disease, which, in most cases, is an inflammatory bowel disease. PG affects more females than males and patients with active colitis. This case report describes a 12‐year‐old girl previously diagnosed with ulcerative colitis (UC) and on infliximab treatment. She came to our attention with a painful leg ulcer during admission for acute respiratory failure and fever. The lesion was classified as PG and a diagnosis of UC pulmonary involvement was made. Infliximab was substitute by ustekinumab and the girl is in remission after 1 year of treatment. To the best of our knowledge, this is the first case in the literature of a UC‐related paediatric PG treated with ustekinumab. Our data suggest that more studies are required as to the efficacy of ustekinumab in paediatric PG settings.

P09 A case of suspected COVID-19 vaccine-induced antiphospholipid syndrome

Abstract A 50-year-old man presented with an acute onset, painful leg ulcer affecting his right calf. This developed 2 weeks after his second COVID-19 vaccine. It started with a painful erythematous plaque, which evolved slowly into a deep-seated 5-cm ulcer over a 6-week period. A thorough review was unremarkable. He had no significant medical history and was a keen athlete and nonsmoker. His father had an unspecified stroke in his 80s. Examination revealed no signs of chronic venous insufficiency or discoloration to his foot, and his neurovascular examination was unremarkable. Investigations for antineutrophil cytoplasm antibodies, antinuclear antibody, complement, paraprotein, HIV and hepatitis were all unremarkable. Biopsy demonstrated nonspecific inflammatory changes, and wound swabs were unremarkable. Initial treatment with oral antibiotics, regular dressings, compression, topical emollients, Dermovate® and prednisolone (0.5 mg kg−1) was only partially effective. He subsequently developed additional painful superficial erosions and ulcers affecting the same limb involving the calf and shin, with a surrounding erythematous livedoid-like rash involving his shin. Rebiopsy demonstrated superficial and deep dermal and subcutaneous thrombosis without vasculitis. Direct immunofluorescence showed the presence of fibrinogen within dermal vessels. Further investigations demonstrated the presence of lupus anticoagulant. Factor V Leiden, protein C and S, anti-B2-GP1 and anticardiolipin antibodies, antithrombin III, homocysteine and coagulation profile were all unremarkable. Histological confirmation of thrombosis and the presence of serum lupus anticoagulant confirmed the diagnosis of antiphospholipid syndrome (APS). He was started on warfarin and the ulcers improved. APS is a rare autoimmune disorder characterized by recurrent miscarriage, thrombophilia and the presence of antiphospholipid autoantibodies (either serum lupus anticoagulant, anti-B2-GP1 or anticardiolipin autoantibodies). Positivity for APS antibodies can be found in up to 5% of the general population. An individual must have the clinical features and antibody positivity to be diagnosed with APS. The temporal relationship with his second COVID-19 vaccine raises the possibility of vaccine-induced APS. COVID-19 vaccine-induced APS is limited to just a few case reports (Moreno-Torres V, Gutiérrez A, Valdenbro M et al. Catastrophic antiphospholipid syndrome triggered by mRNA COVID-19 vaccine. Clin Exp Rheumatol 2022; 40:1054–5). It is postulated that mRNA vaccines may induce a rare complex immunogenic response characterized by a type 1 interferon reaction. This results in a prothrombotic cascade in individuals with pre-existing APS autoantibody positivity (Talotta R, Robertson E. Antiphospholipid antibodies and risk of post-COVID 19 vaccination thrombophilia: the straw that breaks the camel’s back? Cytokine Growth Factor Rev 2021; 60:52–60).

Self-management for sickle cell disease among patients and parents: A qualitative study.

This study aimed to explore self-management practices among patients and parents of children with sickle cell disease (SCD). The qualitative descriptive design was employed. The study involved 19 participants comprising adult SCD patients ≥16 years, and nine parents of SCD children ≤ 15 years. Purposive sampling was conducted to select participants from a teaching hospital and SCD association. Data was collected using one-on-one interviews, transcribed verbatim, and analysed using qualitative content analysis. Self-management was reported through four categories including preventive health, self-monitoring, self-diagnosis, and self-treatment. Hydration, nutrition, activity limitation, avoidance of cold temperatures, and supportive medications were the most common preventive health actions. Regarding self-monitoring and self-diagnosis, the parents emphasized objective indicators such as changes in urine and eye colour compared to the adults who utilize subjective indicators such as feeling unwell and easy fatigue. Pharmacological and non-pharmacological measures were reported by both groups for treating painful episodes, fever, leg ulcers, priapism, and unspecified symptoms. The participants in this study practice several self-management actions with some differences in application between adults and children. Tailored self-management services may be helpful for adults and children when developing services for SCD patients.

A Case of Disseminated Cryptococcus Post-Kidney Transplant

Cryptococcosis is a common invasive fungal infection in solid organ transplant recipients (SOTR) that can be challenging to manage. We discuss a case of disseminated cryptococcosis in a transplant recipient. A 26-year-old woman with a history of ESRD from C1q nephropathy, living-related kidney transplant in early 2012, and allograft nephrectomy in 2015, received a deceased donor kidney transplant (DDKT). Induction after the first transplant was anti-thymocyte globulin (ATG) and maintenance immunosuppression (IS) included tacrolimus (TAC), mycophenolate (MMF), and prednisone. In December 2014, she developed nephrotic range proteinuria due to recurrent FSGS failing plasmapheresis and Intravenous immunoglobulin leading to advanced chronic kidney disease and dialysis dependence. MMF was held due to Cytomegalovirus (CMV) DNAemia. In January 2015, she developed bilateral, painful leg ulcers. Skin biopsy, spinal fluid analysis, and culture were positive for <em>Cryptococcus neoformans.</em> She was treated with liposomal Amphotericin B (LAB) for 3 weeks and 5 doses of flucytosine (5FC) followed by maintenance oral fluconazole with recurrence requiring resumption of LAB and 5FC. The patient underwent a transplant nephrectomy in May 2015 following which IS, LAB, and 5FC were discontinued and maintenance fluconazole initiated. In 2018, another skin biopsy revealed a recurrence. Maintenance antifungal was switched to itraconazole based on fungal isolate minimum inhibitory concentration (MIC) leading to remission that persisted through subsequent DDKT in August 2022. Induction IS was ATG and maintenance included TAC, MMF, and prednisone. The post-transplant course was complicated by delayed graft function requiring dialysis for about three weeks, followed by renal recovery. She continues maintenance of itraconazole under the supervision of a transplant infectious disease specialist and <em>cryptococca</em>l disease remains in remission. IS reduction or complete withdrawal is important in managing disseminated cryptococcosis in SOTR. Management of disseminated disease may require an extended course of LAB, 5FC, and maintenance azole based on MIC.

Ibrutinib response in a patient with refractory mixed essential cryoglobulinemia.

A 74-year-old male presented with fatigue, parasthesiae, Raynaud's phenomena, visual disturbances, and recurrent lower extremity rash (left). Investigations revealed an elevated serum cryoglobulin, rheumatoid factor >1320 IU/ml (ref. <15 IU/mL), undetectable C4, and C3 of 25 mg/dL (ref. 87–200 mg/dL). A small amount of IgM kappa monoclonal protein (M spike of 2.5%) and polyclonal IgG were identified by immunofixation. A diagnosis of mixed (Type II) cryoglobulinemia was made. Testing for Hepatitis B and C was negative. Positron emission/computed tomography (PET-CT) showed no evidence of lymphoma. Although the bone marrow appearance raised suspicion for Waldenstrom macroglobulinemia (WM), testing for MYD88 L265P mutation, which is commonly associated with this disorder, was negative. Of note, scattered CD20-positive B-cells comprised only ∼5% of bone marrow cellularity. The patient's rash gradually evolved into large ulcers over bilateral medial malleoli. Despite treatment with immunosuppression, rituximab, and plasmapheresis, they expanded to 9.3 × 8.9 × 0.3 cm on the left and 8.6 × 5.6 × 0.4 cm on the right (middle), requiring extensive use of opioids and significantly interfering with patient's mobility. A second bone marrow biopsy was again suggestive of WM. However, the frequency of abnormal B-cells was even lower (1.7%), likely reflecting prior therapy. Therefore, B-cells were purified by flow sorting using antibodies against CD19, CD20, and CD38 prior to molecular testing. Critically, this approach revealed the presence of MYD88 L265P mutation, supporting the diagnosis of WM and justifying therapy with Ibrutinib, a Bruton kinase inhibitor which is highly effective in this disease. Starting Ibrutinib 420 mg daily was a clear turning point in the patient's clinical course. After just a few days, he reported a drastic improvement in fatigue and leg ulcer pain. Within the following 2 months, he became pain-free and no longer required narcotics. By the end of the 9 months of therapy, the ulcers were completely healed (right) and quantitative IgM went down from 1058 to 325 mg/dL after the first 3 months. Nearly 2 years since starting the treatment, the patient is asymptomatic except for mild parasthesiae. He continues on Ibrutinib at a lower dose (280 mg daily). Cryoglobulinemia (CG) is a rare multisystem disorder which is caused by immunoglobulins with a capacity to aggregate at lower temperatures (cryoglobulins). Notably, even a small amount of cryoglobulin in the serum is sufficient to cause disease. Hence, a low-burden lymphoproliferative disorder that serves as the source of monoclonal cryoglobulin may be difficult to diagnose, precluding the use of targeted therapies. In agreement with a single prior report [1], our case shows that Ibrutinib can be remarkably effective in refractory CG due to WM. Unexpectedly, we found that despite a near-complete resolution of symptoms with Ibrutinib, the patient's cryoglobulins/IgM paraprotein persisted. In addition, the rheumatoid factor was still elevated, and C4 complement remained undetectable. This suggests that the therapeutic benefit of Ibrutinib may be explained not only by anti-tumor effect but also anti-inflammatory properties, as demonstrated by its efficacy in COVID [2], graft-versus-host disease [3], and autoimmune conditions [4]. Finally, our case shows that enriching for B-cells prior to molecular analysis may aid the diagnosis of occult lymphoproliferative disorder in other patients, for example those with IgM monoclonal gammopathy of clinical significance, who may also benefit from a trial of targeted therapy. H. Jamali wrote the manuscript. D. Wu performed cell sorting and molecular analysis. L. Soma performed morphological assessment of the bone marrow. M. Linenberger contributed to clinical management of the patient (plasma exchange). M. Wener provided rheumatology expertise and co-managed the patient with LS. L. Silberstein provided haematology expertise, co-managed the patient with MW, and wrote the manuscript. The authors have nothing to report. The authors received no specific funding for this work. None of the authors received financial compensation from an external source in return for writing or publishing this paper. The patient consented to the use of their clinical data and photographs for this correspondence.

At-home Topical Sevoflurane Added to the Conventional Analgesic Treatment for Painful leg Ulcers Greatly Improved the Analgesic Effectiveness and Reduced Opioid Consumption in a Single-Center Retrospective Comparative Study with one-Year Follow-up.

The general anesthetic sevoflurane is being repurposed as a topical analgesic for painful chronic wounds. This study was aimed to compare the analgesic effectiveness and safety of systemic analgesics alone or plus at-home topical sevoflurane for the management of patients with painful nonrevascularizable leg ulcers who were referred to a Pain Clinic by their attending vascular surgeons. We reviewed charts of patients treated in a single Pain Clinic with analgesic Standard of Care either alone (group SoC) or plus at-home topical sevoflurane (group SoC + Sevo), according to safety criteria. The area under the curve of pain over a year (AUC-Pain) was the primary outcome for analgesic effectiveness. Opioids were converted into Oral Morphine Milligram Equivalents. Groups SoC (n = 26) and SoC + Sevo (n = 38) were similar in baseline characteristics. Compared to SoC, median values [interquartile range] of area under the curve of pain for one-year follow-up were markedly lower for SoC + Sevo (54 [35-65] vs. 15 [11-23]; p < 0.000001, U Mann-Whitney test). Oral Morphine Milligram Equivalents were similar at baseline (SoC: 78.5 [22.5-135] vs. SoC + Sevo: 101.3 [30-160]; p = 0.753), but significantly lower for SoC + Sevo at three (120 [22.5-202.5] vs. 30 [0-80]; p = 0.005), six (120 [11.3-160] vs. 20 [0-67.5]; p = 0.004), nine (114.4 [0-154] vs. 0 [0-37]; p = 0.018), and 12 months (114.4 [0-154] vs. 0 [0-20]; p = 0.001). Multiple linear regression analysis revealed the addition of sevoflurane to be the most likely variable to explain this difference in outcome (ß:-33.408; p < 0.000001). Nine patients (24%) in SoC + Sevo had adverse effects attributed to sevoflurane, but only one patient needed to stop using sevoflurane due severe dermatitis. In conclusion, the addition of topical sevoflurane to the analgesic standard of care in patients with painful nonrevascularizable leg ulcers was a well-tolerated therapy that significantly improved pain control and allowed for a significant reduction in opioid consumption.

Painful Leg Ulcers in an ESKD Patient.

Painful Leg Ulcers in an ESKD Patient.

A painful leg ulcer.

A painful leg ulcer.

Cost-effectiveness analysis of domiciliary topical sevoflurane for painful leg ulcers

The general anesthetic sevoflurane is being repurposed as a topical analgesic for painful chronic wounds. We conducted a Bayesian cost-effectiveness analysis (CEA) comparing the addition of domiciliary topical sevoflurane to conventional analgesics (SEVOFLURANE, n = 38) versus conventional analgesics alone (CONVENTIONAL, n = 26) for the treatment of nonrevascularizable painful leg ulcers in an outpatient Pain Clinic of a Spanish tertiary hospital. We used real-world data collected from charts to conduct this CEA from a public healthcare perspective and with a one-year time horizon. Costs of analgesics, visits and admissions were considered, expressed in €2016. Analgesic effectiveness was measured with SPID (Sum of Pain Intensity Difference). A Bayesian regression model was constructed, including "treatment" and baseline characteristics for patients ("arterial hypertension") and ulcers ("duration", "number", "depth", "pain") as covariates. The findings were summarized as a cost-effectiveness plane and a cost-effectiveness acceptability curve. One-way sensitivity analyses, a re-analysis excluding those patients who died or suffered from leg amputation, and an extreme scenario analysis were conducted to reduce uncertainty. Compared to CONVENTIONAL, SEVOFLURANE was associated with a 46% reduction in costs, and the mean incremental effectiveness (28.15±3.70 effectiveness units) was favorable to SEVOFLURANE. The estimated probability for SEVOFLURANE being dominant was 99%. The regression model showed that costs were barely influenced by any covariate, whereas effectiveness was noticeably influenced by "treatment". All sensitivity analyses showed the robustness of the model, even in the extreme scenario analysis against SEVOFLURANE. SEVOFLURANE was dominant over CONVENTIONAL as it was less expensive and much more effective.

Compression bandages or stockings versus no compression for treating venous leg ulcers.

Compression bandages or stockings versus no compression for treating venous leg ulcers.

Painful leg ulceration: A case report and concise review of symmetrical Martorell's ulcers

Painful leg ulceration: A case report and concise review of symmetrical Martorell's ulcers

Topical Analgesic and Local Anesthetic Agents for Pain Associated with Chronic Leg Ulcers: A Systematic Review.

To provide information about the effectiveness of topical analgesic and local anesthetic agents for reducing pain associated with chronic leg ulcers. This continuing education activity is intended for physicians, physician assistants, nurse practitioners, and nurses with an interest in skin and wound care. After participating in this educational activity, the participant will:1. Distinguish adverse reactions to topical analgesics and local anesthetic agents.2. Evaluate the effectiveness of topical analgesics and local anesthetic agents for pain associated with chronic leg ulcers.3. Identify substances used as topical analgesics and local anesthetic agents and the application of those agents. To examine the evidence related to the effectiveness of topical analgesic and topical local anesthetic agents for reducing pain associated with chronic leg ulcers.A systematic search and review of the literature were undertaken using key search terms such as leg ulcers, topical anesthetics, topical analgesics, and pain. Six databases were electronically searched for articles published between January 1990 and August 2019.A total of 23 articles were identified that met the inclusion criteria. Data were extracted using content analysis. Most of the included studies were randomized controlled trials; however, the reported methodology for most of studies was poor, so the validity and reliability of the evidence are uncertain. Lidocaine/prilocaine cream, ibuprofen foam, and morphine gel were the most examined topical agents. Lidocaine/prilocaine cream significantly improved wound-related pain compared with all other studied agents. For topical analgesic agents, ibuprofen foam reduced chronic leg ulcer pain significantly, whereas morphine gel was ineffective.Lidocaine/prilocaine cream and ibuprofen foam are effective agents for reducing wound-related pain associated with chronic leg ulcers. Effective use of topical agents could reduce the need for systemic pain relief agents, mitigating potential adverse effects, while giving clinicians another treatment option to manage wound-related pain associated with chronic leg ulcers.

Two-layer reduced compression system for lower limb wounds: a non-comparative evaluation.

Leg ulceration is a debilitating condition in which various factors play a role in determining patients' quality of life (QoL), and compression therapy has been shown to improve QoL. The 3M Coban 2 Lite Compression System provides reduced compression (25-30 mmHg) ideal for patients with painful venous leg ulcers (VLU) who are unable to tolerate high-strength compression or those with mixed-aetiology leg ulcers (MLU) who have an ankle-brachial pressure index (ABPI)≥0.5. This non-comparative evaluation aims to report the initial clinical experiences with 3M Coban 2 Lite and evaluate the performance of this two-layer reduced compression bandage system in treating chronic VLUs and MLUs. In total, 30 patients (12 men (40%); mean age=68.5 years) were enroled for evaluation. The duration of the chronic wounds was 28 months (range=1.5-144 months); 16 patients had VLUs, while 14 had MLUs. Complete healing was achieved in 6 (20%) patients, and an overall mean reduction in wound surface area (4.11 cm2) was observed between the baseline and study endpoint (16 weeks). Thus, 3M Coban 2 Lite seems safe and effective for treating painful VLUs and MLUs in patients unable to tolerate high-strength compression.

A rare complication of ulcerative colitis in children: Pyoderma gangrenosum

Pyoderma gangrenosum (PG) is a rare inflammatory skin disease mainly characterized by ulcers. More than half of the PG is associated with systemic diseases like inflammatory bowel disease. About 4% of PG is seen during childhood. Here we report a 12-year-old girl presented with fever and bloody diarrhea and who developed a painful leg ulcer during follow up period and diagnosed as ulcerative colitis.

Pain in persons with chronic venous leg ulcers: A systematic review and meta-analysis.

Pain is a serious problem for patients with leg ulcers. Research mainly focuses on dressing‐related pain; however, chronic background pain may be just as devastating. Our main objective was to describe the prevalence and characteristics of wound‐related background pain in persons with chronic venous leg ulcers. We performed a systematic review to synthesise data from quantitative studies. Studies were eligible if they reported original baseline‐ or cross‐sectional data on background pain in chronic venous leg ulcers. The initial search identified 2454 publications. We included 36 descriptive and effect studies. The pooled prevalence of wound‐related background pain (from 10 studies) was 80% (95% CI 65‐92%). The mean pain intensity score (from 27 studies) was 4 (0‐10 numeric rating scale) (95% CI 3.4‐4.5). Other pain characteristics could not be synthesised. We identified few sufficiently high‐quality studies on prevalence and intensity of wound‐related background pain in patients with chronic venous leg ulcers. Four of five persons experience mild to moderate pain. Because of poor quality of pain assessment and report, we believe that the available research does not provide a sufficiently nuanced understanding of background pain in this patient group.

Therapeutic Effect of a Traditional Chinese Medicine on the Treatment of Painful Leg Ulcer

This study aimed to investigate the therapeutic effect of a traditional Chinese medicine on the treatment of painful leg ulcer. Twelve cases of painful leg ulcer were recruited and their characteristics (etiology, size, Visual Analog Scale score, and duration) were recorded. Then, an herbal medicine-oriented treatment protocol combining Zhi Tong Sheng Ji powder (ZTSJ) and SJXP (Sheng Ji Xiang Pi plaster) was applied to these patients. The results suggested that this therapeutic protocol contributed to pain relief and promoted wound healing simultaneously. Specifically, 2 days after applying ZTSJ on wounds, the intensity of pain reduced substantially, and the difference between pre- and post-treatment Visual Analog Scale scores (46 mm vs 23 mm, P < .001) was statistically significant. Epithelialization varied according to ulcer depth. If the wound was deep to the fascia, islands of epithelia did not form within wounds, but rather formed at the edge of wounds, generating island of epithelial cells (IECs) or newly formed epithelial tissue. If the wound was superficial and the dermis remained, scattered IECs appeared within ulcers and merged eventually. Furthermore, as wound pain decreased, IECs appeared, expanded, and merged, or epithelial proliferation and migration occurred in wound margin, eventually healing wounds. No infection spread, topical rashes, itching, or other allergies occurred in these 12 cases, and the time for recovery ranged from 16 to 163 days. ZTSJ is effective for the treatment of painful leg ulcers, but the specific mechanism is not clear.

Diagnosis and treatment of painful leg ulcers

Painful leg ulcers are very common in clinic, including arterial ulcers, venous ulcers, autoimmune diseases-related ulcers, gangrenous pyoderma, necrobiosis lipoidica and hypertensive ulcers. At present, few painful leg ulcer-related researches have been conducted in China, and pain is only treated as a concomitant symptom of leg ulcers. However, a series of painful leg ulcer-related researches have been carried out in other countries. This review comprehensively expounds the definition, epidemiological characteristics, etiology and management of, as well as pain mechanism and assessment in painful leg ulcers. Key words: Leg ulcer; Pain; Pain management; Therapy

A Challenging Diagnosis of Leg Ulcer.

Ischaemic ulcers of the lower limb can have several aethiopathological mechanisms. For instance, the uncommon Martorell hypertensive leg ulcer is an infrequent complication of long-term uncontrolled arterial hypertension and is largely ignored and underdiagnosed. The typical ulcer is on the lower leg, is extremely painful and presents in female patients over 60 years of age with cardiovascular risk factors, mainly severe arterial hypertension. The diagnosis is histological, with obliteration of the arterioles by arteriolosclerosis. In these cases, antihypertensive medication is the standard treatment. We describe the case of an African-American female patient with long-term hypertension who presented with a very painful leg ulcer. The diagnosis was complicated by the coexistence of more common causes of ulcer. Despite analgesic medicines, pain relief was only obtained with control of hypertension. A definite diagnosis was made following biopsy.In describing this diagnosis of an ischaemic leg ulcer, we highlight the need to consider the skin as a target organ of arterial hypertension.LEARNING POINTSMartorell hypertensive leg ulcer is an underdiagnosed cutaneous lesion arising from long-term uncontrolled hypertension.The diagnosis is confirmed by histopathology.Standard treatment is adequate control of blood pressure.

Eutectic mixture of local anaesthetics (EMLA\xae) as a primary dressing on painful chronic leg ulcers: a pilot randomised controlled trial

BackgroundThe physical, occupational, social and psychological impact of chronic leg ulcers (CLUs) on an individual is considerable. Wound-related pain (WRP), the most common symptom, is frequently reported as moderate to severe and mostly occurs at dressing change. WRP pain may not be alleviated by oral analgesics alone. Persistent poorly controlled leg ulcer pain can negatively impact wound healing and health-related quality of life (HRQoL).MethodsA pilot, parallel group, non-blinded, randomised controlled trial was conducted in six procedure clinics located in a public community nursing service in New South Wales, Australia to evaluate eutectic mixture of local anaesthetics (EMLA®) on painful CLUs when used as a primary dressing. The primary objective was to assess feasibility by using pre-determined criteria: at least 80% recruitment rate, 80% retention rate and 80% adherence to the study protocol. Key eligibility criteria were that participants had a painful CLU no larger than 100 cm2, a numerical rating scale (NRS) wound-related pain intensity score equal to or greater than 4, low to moderate exudate, no contraindications to EMLA® and capacity to consent. One hundred and seven patients with painful CLUs were screened for eligibility; 56% (n = 60) were eligible and consented to participate in the study. Participants were randomly assigned to the intervention (n = 30) or control (n = 30) groups. The intervention group received a measured dose of the topical anaesthetic EMLA® 5% cream daily as a primary dressing for 4 weeks followed by usual wound management for a further 8 weeks. The control group received usual wound management. Participants and investigators were not blinded to the treatment. WRP was measured at every dressing change. Wound healing and HRQoL were measured at baseline, 4 and 12 weeks.ResultsRecruitment rate was lower than expected which likely meant patients were missed. Study retention rate was 90% (n = 54). Intervention fidelity was impacted by availability of resources and patient factors such as increased WRP.ConclusionThis study identified that a larger randomised controlled trial investigating EMLA® applied as a primary dressing on painful chronic leg ulcers is feasible with modifications to the study protocol.Trial registrationAustralian New Zealand Clinical Trials Register: Registered 16 December, 2009

The psychosocial impact of leg ulcers in patients with sickle cell disease: I don't want them to know my little secret.

BackgroundSickle cell disease (SCD) impacts millions of individuals worldwide and more than 100,000 people in the United States. Leg ulcers are the most common cutaneous manifestation of SCD. The health status of individuals living with chronic leg ulcers is not only influenced by clinical manifestations such as pain duration and intensity, but also by psychosocial factors. Garnering insights into the psychosocial impact can provide a more holistic view of their influence on quality of life.MethodsSemi-structured interviews were conducted with participants living with active SCD-associated leg ulcers or with a history of ulcers. Subjects were recruited from an ongoing study (INSIGHTS, Clin Trial.Gov NCT02156102) and consented to this qualitative phase of the study. Five areas were explored: leg ulcer pain, physical function, social-isolation, social relationships and religious support. Data was collected from 20 individuals during these interviews and a thematic analysis was performed and reported.ResultsTwenty participants with a mean age of 42.4 (SD ± 11.1years) were included in the study. Major themes identified included:1) pain (acute and chronic); 2) compromised physical function as demonstrated by decreased ability to walk, run, and play sports; 3) social isolation from activities either by others or self-induced as a means of avoiding certain emotions, such as embarrassment; 4) social relationships (family support and social network); 5) support and comfort through their religion or spirituality.ConclusionsSCD patients with leg ulcers expressed that they experience social isolation, intense and frequent ulcer pain, and difficulty in physical function. SCD-associated leg ulcers have been studied from a clinical approach, but the psychosocial factors investigated in this study informs how quality of life is impacted by the leg ulcers.