DermACELL in Subjects With Chronic Wounds of the Lower Extremities

NCT ID: NCT01970163

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-04-30

Brief Summary

The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).

Detailed Description

This study is designed to demonstrate the effectiveness of DermACELL in the treatment of chronic wounds of the lower extremities. DermACELL will be compared to conventional care in both subjects with diabetic foot ulcers (DFU) and subjects with venous stasis ulcers (VSU). In addition, DermACELL will be compared to an active comparator, GraftJacket, in subjects with diabetic foot ulcers.

DermACELL and GraftJacket are both made from donated human skin (dermis). These products have been processed so that cells are removed and bacteria and viruses are destroyed. This processing provided a supporting structure, an acellular dermal matrix, into which cells can migrate and divide during the wound healing process.

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DermACELL

DermACELL acellular dermal matrix will be used to treat subjects diagnosed with an ulcer of the lower extremity (diabetic foot ulcer or venous stasis ulcer).

Group Type: EXPERIMENTAL

DermACELL

Intervention Type: OTHER

Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).

Conventional care dressings

Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diagnosis of either diabetic foot ulcer or venous stasis ulcer.

Group Type: PLACEBO_COMPARATOR

Conventional Care Dressings

Intervention Type: OTHER

Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:

• If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.
• Hydrogels can also be used if the wound is in need of moisture.
• For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.

A secondary dressing may be desired to add either loft or cushion.

GraftJacket

GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer.

Group Type: ACTIVE_COMPARATOR

GraftJacket

Intervention Type: OTHER

Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).

Interventions

DermACELL

Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).

Intervention Type: OTHER

GraftJacket

Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).

Intervention Type: OTHER

Conventional Care Dressings

Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:

• If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.
• Hydrogels can also be used if the wound is in need of moisture.
• For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.

A secondary dressing may be desired to add either loft or cushion.

Intervention Type: OTHER

Other Intervention Names

LifeNet Health Product Code: DCELL112; KCI Product Code: GJ44

Eligibility Criteria

Inclusion Criteria

• Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off-loading requirements of treatment;
• If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days;
• Have a DFU that has been present for at least 30 days or have a VSU that has been present for at least 60 days;

Exclusion Criteria

• Have a DFU or VSU that is infected;
• Are pregnant or lactating;
• Have an allergy or are sensitive to one of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin;
• Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol;
• Have had a HbA1c level greater than 12% within the past 90 days;
• Have liver function tests or kidney function tests that are very elevated;
• Have a known or suspected disease of the immune system;
• Have had surgery in the past 30 days to increase blood flow into your leg or foot;
• Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis);
• Have undergone wound healing treatment with a living skin equivalent (i.e., Dermagraft®, Apligraf®, TheraSkin®, Oasis®, GraftJacket®, Integra®, Alloderm®) or topical growth factors in the last 4 weeks;
• Have active Charcot disease, a weakening of the bones in the foot that can occur in people who have significant nerve damage (neuropathy);

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeNet Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Moore, Ph.D.

Role: STUDY_DIRECTOR

LifeNet Health, Scientific Affairs

Locations

Institute for Advanced Wound Care

Montgomery, Alabama, United States

Southern Arizona VA Health Care System

Tucson, Arizona, United States

ILD Research Center

Carlsbad, California, United States

Center for Clinical Research

Castro Valley, California, United States

Limb Preservation Platform

Fresno, California, United States

Limb Preservation Platform

Fresno, California, United States

Fairfield County Foot Surgeons

Norwalk, Connecticut, United States

Andrews Research and Education Institute

Gulf Breeze, Florida, United States

Rosalind Franklin University, CLEAR

North Chicago, Illinois, United States

Boston Medical College

Boston, Massachusetts, United States

Wound Institute and Reseach Center

Dunmore, Pennsylvania, United States

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Eplasty. 2016 Feb 4;16:e10. eCollection 2016.

Reference Type: RESULT

PMID: 26933467 (View on PubMed)

Cazzell S, Vayser D, Pham H, Walters J, Reyzelman A, Samsell B, Dorsch K, Moore M. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017 May;25(3):483-497. doi: 10.1111/wrr.12551. Epub 2017 Jun 12.

Reference Type: RESULT

PMID: 28544150 (View on PubMed)

Other Identifiers

CR-13-001

Identifier Type: -

Identifier Source: org_study_id