Chronic Venous Hypertension With Ulcer
Conditions
Brief summary
This study will compare the efficacy of using standard compression therapy for treatment of chronic venous leg ulcers vs. the standard compression therapy with the additional use of the application of a human allograft (Theraskin)
Detailed description
Given the propensity for venous leg ulcers to become refractory, long standing wounds, incorporating active biologic grafts into the standard compression therapy, may prove to accelerate wound healing. The two treatments to be compared in this study are both commonly used for the treatment of venous leg ulcers. Compression therapy has long been the standard for the treatment of venous leg ulcers. Standard Compression therapy consists of wound debridement, application of non adherent dressings and a three or four layer compression dressing. (PROFORE Multi-Layer Compression Bandage System) TheraSkin is a split thickness skin graft harvested within 24 hours postmortem, from an organ donor who has cleared the standard safety screenings. It is classified by the FDA as a donated tissue. Once harvested, the graft is sanitized according to FDA specifications, and cryopreserved, until it is delivered to the clinic for application to the foot ulcer. It is also a widely used treatment for diabetic foot ulcers. TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a substantial proportion of the population. Venous leg ulcers (VLUs) account for up to 90% of lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the United States is Standard Compression therapy as described above, which may be combined with biologic graft materials applied to the wound bed. This study may assist physicians who treat VLU's by comparing efficacy and costs of two common treatments for VLU's in a prospective randomized clinical trial. The investigation will be a head-to-head study comparing widely used human skin allograft (Theraskin) along with Standard Compression Therapy vs Standard Compression Therapy alone. There is no randomized, prospective data comparing these two options in the treatment of VLU. Compression is superior to no compression and increases VLU healing rates. It is currently the mainstay of treatment for venous ulcers of the lower extremities. It is important to consider the underlying pathophysiology of these wounds. A history of deep vein thrombosis is regarded as a predisposing factor to venous insufficiency, and hence venous ulceration. Venous insufficiency is associated with increased hydrostatic pressure in the veins of the leg (Moffatt 207). External compression attempts to reverse this and aids venous return
Interventions
PROCEDUREStandard Multi-layered Compression dressing
Compression therapy with a multi-layered compression dressing for the treatment of venous leg ulceration
PROCEDUREStandard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)
Application of a cryopreserved skin allograft (TheraSkin) beneath compression therapy with a multi-layered compression dressing.
Sponsors
Solsys Medical LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization. 1. Adult patients with venous leg ulcer(s) \>1 month. 2. A signed and dated informed consent form. 3. Subject is able to comply with instructions and scheduled visits, not confined to bed,. 4. Ulcer surface area \>2cm2 but not \>10cm in any dimension. The total not to exceed 18cm2 5. ABPI \>.8, Doppler ultrasound (biphasic or triphasic waveforms) consistent with adequate blood flow to the affected extremity, as determined by the Investigator. 6. There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified leg, post-debridement) Note: If the subject has more than one qualifying VLU, the ulcer designated as the study ulcer will be at the discretion of the Investigator.. 7. Casual smoker not exceeding one pack per week -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of wound healing, percentage of wounds that close, and change in wound size in subjects with venous leg ulcers treated with compression therapy with or without a cryopreserved skin allograft (TheraSkin) | Enrollment and data analysis is anticipated to require approximately 3 years. | Monitor changes in wound healing rate, percentage of wounds that close, and changes in wound size associated with two cohorts (multi-layered compression therapy vs. multi-layered compression therapy used in conjunction with a cryopreserved skin allograft. |
| Determine the number and severity of adverse events associated with the two treatment cohorts -- standardized multi-layered compression therapy and the same therapy with a cryopreserved skin allograft added. | Enrollment and data analysis is anticipated to require approximately 3 years. | Measure the frequency and severity of adverse events associated with each treatment cohort. |
Countries
United States
Outcome results
None listed