Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft
Diabetic Foot Ulcer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Proposal for a Multi- Center Site Randomized, Prospective Controlled Head-to-head Clinical Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograf|
- Proposal for a multi center site randomized, prospective controlled head-to-head clinical trial comparing a bioengineered skin substitute to a human skin allograft. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers, data comparing one type of modality to another are scarce. This investigation is a prospective randomized study comparing a bioengineered skin substitute to a human skin allograft.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
The primary goal in treating a DFU is to obtain wound closure. Healing can be a lengthy and painful process for ulcers of diabetic etiology. Healing is often further complicated in subjects with diabetes by vascular compromise and peripheral ischemia, renal insufficiency and diminution of inflammatory responses
The two products to be compared in this study are both commonly used for the treatment of diabetic foot ulcers. DermaGraft is considered a medical device by the FDA, and was cleared for the treatment of diabetic foot ulcers in 1997. It is a staple for the treatment of diabetic foot ulcers, and is widely used throughout the United States. It is composed of an absorbable substrate that has been seeded with living human fibroblasts. Once formed, the graft is cryopreserved until it reaches the clinic, where it is defrosted and applied to the wound surface.
TheraSkin is composed of a split thickness skin graft harvested within 24 hours post-mortem, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676272
|United States, Pennsylvania|
|Washington Hospital Wound Center|
|Washington, Pennsylvania, United States, 15301|
|United States, Virginia|
|Mary Immaculat Hospital Wound Care Center|
|Newport News, Virginia, United States, 23602|
|Principal Investigator:||Nelson Keller, DPM||Mary Immaculate Hospital|