Skip to main content
OpenTrials
Completed

NCT Number: NCT01970163

DermACELL in Subjects With Chronic Wounds of the Lower Extremities

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Advanced Wound Care, Montgomery, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);

Treatment and study plan

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).

Other names: LifeNet Health Product Code: DCELL112

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).

Other names: KCI Product Code: GJ44

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.

Primary outcomes

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

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 24 weeks

    The proportion of subjects with closed wounds at 12 weeks and weekly thereafter will be compared in subjects treated with DermACELL, GraftJacket (Diabetic foot ulcer subjects only) and conventional care wound management. A comparison of the proportion of subjects who received a second application of acellular dermal matrix will be made between the DermACELL and GraftJacket arms in those subjects with diabetic foot ulcers.

Other outcomes

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

    Time frame: 24 weeks

    Safety of the interventions will be measured by the incidence of treatment-emergent AEs, changes in vital signs, ABI and physical examination.

Sponsors and collaborators

Lead sponsor

LifeNet Health

Industry

Registry information

Official study title

A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 25, 2013
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.