Comparison of Human Allograft to Apligraf for Venous Leg Ulcers

NCT02047084 | Enrolling By Invitation DMC

• 1 other identifier: Venous Leg Ulcer Head to Head
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Given the propensity for venous leg ulcers to become refractory, long standing lesions, incorporating active biologic grafts into the standard compression therapy, has shown to accelerate wound healing. The two products to be compared in this study are both commonly used for the treatment of venous leg ulcers. Apligraf is considered a medical device by the FDA, and was cleared for the treatment of venous leg ulcers in 1998. It is a staple for the treatment of venous leg ulcers, and is widely used throughout the United States. It is composed of a type 1 collagen matrix in which human foreskin-derived neonatal fibroblasts are grown, and over which human foreskin-derived neonatal keratinocytes are then cultured and allowed to stratify. 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. TREATMENT RATIONALE FOR THIS STUDY Chronic wounds of the lower extremities affect a substantial proportion of the population. Venous leg ulcers (VLU) account for 40-70% of lower extremity wounds. The standard of care for treatment of VLU's in wound centers in the United States is compression therapy combined with application of biologic graft materials to the wound bed. This study may assist physicians who treat VLU's by comparing efficacy and costs of two commonly used biologic graft materials for VLU's in a randomized prospective study. In addition to standard compression therapy, this investigation will be a head-to-head study comparing widely used bio-engineered skin substitute (Apligraf) to cryopreserved, human skin allograft (Theraskin). There is no randomized, prospective data comparing these two graft options in the treatment of VLU's.

Conditions

Venous Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• Wound Closure outcome using one of two cohorts that has be randomly selected

  The study treatment will be administered and the patient will be followed until the study ulcer has completely healed (i.e., 100% closure as determined by the Investigator, for up to 12 weeks. During the Treatment Phase subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of wound closure and evaluations of ulcer size.

  Wound healing outcome will be evaluated at 12 weeks

Secondary Outcomes (1)

• Follow up time after closure or failure for closure of Venous Leg Ulcerations

  Successful or failed wound closure is to be measured within 8 weeks following the intial 12 week measurement

Study Arms (2)

Theraskin, Apligraf

Theraskin used every other week x 4 Apligraf used weekly x 8

Venous leg ulcers

Theraskin and Apligraft

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Chronic Venous Leg wounds

You may qualify if:

• A signed and dated informed consent form has been obtained from the subject.
• Subject is 18yrs or older and able and willing to comply with study procedures.
• Ulcer size (area) is \>2cm2 but \<40cm2 (post-debridement at time of randomization) and not deeper than 5mm.
• Study ulcer duration is \>30days despite conventional wound care at the time of screening visit.
• 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.
• \. Subject has adequate arterial perfusion with an ankle brachial index \>0.5 or biphasic or triphasic Doppler signals in the dorsalis pedis and posterior tibial arteries of the affected extremity.

You may not qualify if:

• Subject has suspected 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 collage and agarose shipping media as listed in the Apligraf 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 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 ulcers secondary to a disease other than venous ulcers, e.g., vasculitis, neoplasm's, or hematological disorders.
• Subject has osteomyelitis with necrotic soft bone. (If the Investigator suspects the presence of osteomyelitis, the diagnosis must be confirmed by plain film X-ray.)
• Subject has a history of bone cancer or metastatic disease on the affected limb, radiation therapy to the foot or has had chemotherapy within the 12 months prior to randomization.
• Subject has been treated with wound dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex®, Dermagraft®, Apligraf®, TheraSkin®, GraftJacket®, OASIS®, Primatrix®, Matristem®, etc.) within 30 days of randomization.
• Subject has a history of or any of the following current illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process:
• End-stage renal disease
• Immunosuppression
• Severe malnutrition

Sponsors & Collaborators

• Solsys Medical LLC: lead

Study Sites (1)

St. Francis Wound Healing Center

Greenville, South Carolina, 29615, United States

Location

Study Officials

• Michael A. Towler, MD

  St. Francis Wound Care Center

  PRINCIPAL INVESTIGATOR

• Arnold R Landsman, DPM

  Soluble Systems

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: January 28, 2014
• Study Start: June 1, 2013
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)