Proposal for a Multi- Center Site Randomized, Prospective Controlled Head-to-head Clinical Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograf
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- Solsys Medical LLC
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Proposal for a multi center site randomized, prospective controlled head-to-head clinical trial comparing a bioengineered skin substitute to a human skin allograft.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •: Subjects are required to meet all of the following criteria for enrollment into the study and subsequent randomization.
- •A signed and dated informed consent form has been obtained from the subject.
- •Subject is able and willing to comply with study procedures
- •Subject is male or female and is 18 years of age or older.
- •Subject, if female of childbearing potential, has a negative serum pregnancy test at screening
- •Subject has type 1 or type 2 diabetes mellitus
- •Subject has glycosylated hemoglobin, HbA1c, less than or equal to 12%
- •Presence of at least one DFU that meets all of the following criteria:
- •Ulcer has been diagnosed as a full-thickness DFU and including those of the heel.
- •There is a minimum 2 cm margin between the qualifying study ulcer and any other ulcers on the specified foot, post-debridement)
Exclusion Criteria
- •Subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
- •Subject has suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the affected limb. (Subjects with wound infection at the screening visit may be treated and re-screened for participation in the study after eradication of the infection).
- •Subject has a history of hypersensitivity to bovine collagen and/or chondroitin, as listed in the Dermagraft Directions for Use.
- •Subject has a history of hypersensitivity to any of the antibiotics or preservation agents listed in the TheraSkin Instructions for Use.
- •Subject cannot be pregnant at the time of treatment.
- •Subject was previously treated under this clinical study protocol.
- •Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of randomization visit.
- •Subject is currently receiving (i.e., within 30 days of randomization visit) or scheduled to receive a medication or treatment which, in the opinion of the Investigator, is known to interfere with or affect the rate and quality of wound healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, cytostatic therapy within the 12 months prior to randomization, dialysis, radiation therapy to the foot, vascular surgery, angioplasty or thrombolysis).
- •Subject has any of the following unstable conditions or circumstances that could interfere with treatment regimen compliance:
- •Ability to perform required dressing changes
Outcomes
Primary Outcomes
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
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.