View clinical trials related to Leg Ulcer.
Filter by:This study was designed to evaluate the clinical benefits and safety of OrCel in the treatment of venous ulcers. OrCel and standard care were compared to standard care alone. Standard care consisted of currently accepted compression therapy. Patients were treated for 12 weeks. Patients with healed ulcers were followed for an additional 12 weeks to assess durability of the healed wound.
Current treatment modalities for chronic leg ulcers are time consuming, expensive, and only moderately successful. Recent data suggest that creating a sub-atmospheric pressure by Vacuum Assisted Closure (V.A.C.®) therapy supports the wound healing process. Here, we studied the efficacy of V.A.C.® in the treatment of chronic leg ulcers prospectively.
This is a randomized (1:1), prospective, open label, multicenter, comparative study to be examine the effectiveness of Collagen-ORC Antimicrobial matrix, a new wound dressing, on venous leg ulcers.
The main purpose of the study is to compare treatment of non-infected venous leg ulcers using ICXP007 combined with four-layer compression bandaging, placebo combined with four-layer compression bandaging and four-layer compression bandaging alone.
Leg ulcers are often chronic or recurring complications of peripheral circulation disorders. Patients' lifestyles are known to influence leg ulcer occurrence and circulation disorders in general. Especially exercise and compliance with compression therapy are key elements in the course of leg ulcer healing and recurrence. Yet many patients demonstrate sedentary lifestyles and non-compliance and current practice offers no systematic approach in the promotion of compliance and physical activity in these patients. The purpose of the study is testing 'Lively Legs' a compliance promotion program for patients with leg ulcers. The study tests the program on effects regarding: - compliance with compression therapy and exercise levels - time to leg ulcer recurrence - cost effectiveness from a social perspective.
A Seattle VA study indicated lower extremity ulcers preceded 84% of diabetic amputations. Nearly half of the events that ban the causal chain leading to ulcers and amputation were initiated by ill-fitting footwear. Other investigators report similar findings for injurious footwear in their diabetic patient populations. Yet, the efficacy of footwear in preventing ulcers and amputations in the high-risk diabetic population has received limited experimental investigation. A British descriptive study followed diabetic patients with healed foot ulcers for two years and found reulceration occurred in 72% of patients who resume wearing their own footwear compared to 26% of patients who continued wearing "prescribed" footwear. A Swedish cohort study identified individuals with a foot ulcer and reported their 1, 3, and 5 year reulceration rates at 34%, 61%, and 70%, respectively, without further specifying footwear components. In a German diabetic population the reulceration rate was 87% in-patients who abandoned their custom shoes and resumed wearing their own shoes compared to 42% of those who continued to wear their custom shoes. Unfortunately, none of these studies compared the single or combined contribution of therapeutic shoes or insoles on foot ulcer prevention. Nor did these studies address patient adherence to prescribed footwear; thus the actual efficacy of various footwear interventions in foot ulcer prevention in this high-risk population is still to be tested.
This study will look at whether a graft of bioengineered skin (BSC), known commercially as Apligraf, stimulates the healing process in a person's own skin at the edge of a wound (known as the edge effect). The information from this study will provide a better understanding of the ways that grafts of bioengineered skin help the healing of chronic wounds. We will assign study participants to either the bioengineered skin group or the control group. People in the control group will receive compression therapy with a multilayered compression bandage. We will examine each participant before starting treatment and then once a week for 24 weeks or until the wound heals. On the first day of treatment (day 0) and at week 3, week 6, and week 24 (end of treatment) we will take a small tissue sample from the wound for a biopsy. After the wound is completely healed, we will ask the patient to return once a month for 6 months to make sure the wound stays healed.