DermACELL in Subjects With Chronic Wounds of the Lower Extremities

NCT01970163 | Completed

• 1 other identifier: CR-13-001
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Keywords

Diabetic foot ulcer; Venous stasis ulcer; Wound of the lower extremity; Skin substitute; Acellular Dermal Matrix

Outcome Measures

Primary Outcomes (1)

• Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.

  The primary outcome is the comparison of the proportion of chronic wounds treated with DermACELL and treated with conventional care that have achieved 100% re-epithelialization without dressing or drainage requirements at 12 weeks. Wound closure is defined as first observation of 100% re-epithelialization without drainage or dressing requirements and complete wound closure is defined as 100% re-epithelialization without dressing or drainage requirements confirmed at two consecutive study visits 2 weeks apart.

  12 weeks

Secondary Outcomes (1)

• Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks

  24 weeks

Other Outcomes (1)

• Incidence of treatment-emergent adverse events (AE), changes in vital signs, ankle-brachial index (ABI) and physical examination findings.

  24 weeks

Study Arms (3)

DermACELL

EXPERIMENTAL

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).

Other: DermACELL

Conventional care dressings

PLACEBO COMPARATOR

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.

Other: Conventional Care Dressings

GraftJacket

ACTIVE COMPARATOR

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

Other: GraftJacket

Interventions

DermACELL 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).

Also known as: LifeNet Health Product Code: DCELL112

DermACELL

GraftJacket 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).

Also known as: KCI Product Code: GJ44

GraftJacket

Conventional Care Dressings 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.

Conventional care dressings

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• LifeNet Health: lead

Study Sites (12)

Institute for Advanced Wound Care

Montgomery, Alabama, 36111, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

ILD Research Center

Carlsbad, California, 92009, United States

Location

Center for Clinical Research

Castro Valley, California, 94546, United States

Location

Limb Preservation Platform

Fresno, California, 93720, United States

Location

Limb Preservation Platform

Fresno, California, 93721, United States

Location

Fairfield County Foot Surgeons

Norwalk, Connecticut, 06851, United States

Location

Andrews Research and Education Institute

Gulf Breeze, Florida, 32561, United States

Location

Rosalind Franklin University, CLEAR

North Chicago, Illinois, 60064, United States

Location

Boston Medical College

Boston, Massachusetts, 02118, United States

Location

Wound Institute and Reseach Center

Dunmore, Pennsylvania, 18512, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

• 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.

  PMID: 26933467 RESULT

• 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.

  PMID: 28544150 RESULT

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

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; Varicose Veins

Study Officials

• Mark Moore, Ph.D.

  LifeNet Health, Scientific Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 25, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: March 14, 2018

Record last verified: 2018-03

Locations

US (12)