Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft

NCT01676272 | Completed

• 1 other identifier: soluble 102
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Proposal for a multi center site randomized, prospective controlled head-to-head clinical trial comparing a bioengineered skin substitute to a human skin allograft.

  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.

  2 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population includes Diabetic patients with type 1 or type 2 Diabetes with foot ulcers

You may qualify if:

• 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)
• Ulcer size (area) greater than 1 cm2 (post-debridement at time of randomization) not deeper than 5mm. deep. Ulcer size no larger than 10 cm2
• Wagner grade 1 at initialization of the clinical trial
• Duration of the study ulcer is at least 30 days at the time of the screening visit Note: If the subject has more than one qualifying DFU, the ulcer designated as the study ulcer will be at the discretion of the Investigator.
• Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following:
• Ankle-Brachial Index (ABI) at least 0.65 (moderate arterial disease) and less than1.2
• Toe pressure (plethysmography) \> 50 mm Hg

You may not qualify if:

• 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
• Ability to comply with treatment visit schedule
• Mental incapacity
• Current substance abuse
• Subject has excessive lymphedema, which, in the opinion of the Investigator, could interfere with wound healing.
• Subject has unstable Charcot foot or Charcot with boney prominence that, in the opinion of the Investigator, could inhibit wound healing.
• Subject has ulcers secondary to a disease other than diabetes, e.g., vasculitis, neoplasm's, or hematological disorders.

Sponsors & Collaborators

• Solsys Medical LLC: lead

Study Sites (2)

Washington Hospital Wound Center

Washington, Pennsylvania, 15301, United States

Location

Mary Immaculat Hospital Wound Care Center

Newport News, Virginia, 23602, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Nelson Keller, DPM

  Mary Immaculate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: August 30, 2012
• Study Start: July 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 26, 2019

Record last verified: 2015-11

Locations

US (2)