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DermACELL in Subjects With Chronic Wounds of the Lower Extremities

Primary Purpose

Diabetic Foot Ulcer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DermACELL
GraftJacket
Conventional Care Dressings
Sponsored by
LifeNet Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Diabetic foot ulcer, Venous stasis ulcer, Wound of the lower extremity, Skin substitute, Acellular Dermal Matrix

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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);

Sites / Locations

  • Institute for Advanced Wound Care
  • Southern Arizona VA Health Care System
  • ILD Research Center
  • Center for Clinical Research
  • Limb Preservation Platform
  • Limb Preservation Platform
  • Fairfield County Foot Surgeons
  • Andrews Research and Education Institute
  • Rosalind Franklin University, CLEAR
  • Boston Medical College
  • Wound Institute and Reseach Center
  • VA Pittsburgh Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

DermACELL

Conventional care dressings

GraftJacket

Arm Description

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).

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2013
Last Updated
March 12, 2018
Sponsor
LifeNet Health
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1. Study Identification

Unique Protocol Identification Number
NCT01970163
Brief Title
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
Official Title
A Multicenter, Randomized, Controlled, Open Label Trial of DermACELL in Subjects With Chronic Wounds of the Lower Extremities
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeNet Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
Keywords
Diabetic foot ulcer, Venous stasis ulcer, Wound of the lower extremity, Skin substitute, Acellular Dermal Matrix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DermACELL
Arm Type
Experimental
Arm Description
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).
Arm Title
Conventional care dressings
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
GraftJacket
Arm Type
Active Comparator
Arm Description
GraftJacket acellular dermal matrix will be used in those subjects diagnosed with a diabetic foot ulcer.
Intervention Type
Other
Intervention Name(s)
DermACELL
Other Intervention Name(s)
LifeNet Health Product Code: DCELL112
Intervention Description
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
Intervention Name(s)
GraftJacket
Other Intervention Name(s)
KCI Product Code: GJ44
Intervention Description
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
Intervention Name(s)
Conventional Care Dressings
Intervention Description
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 Outcome Measure Information:
Title
Effect of DermACELL on the proportion of chronic wounds of the lower extremity that have healed.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Proportion of wounds closed at 12 weeks and weekly thereafter for up to 24 weeks
Description
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.
Time Frame
24 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of treatment-emergent adverse events (AE), changes in vital signs, ankle-brachial index (ABI) and physical examination findings.
Description
Safety of the interventions will be measured by the incidence of treatment-emergent AEs, changes in vital signs, ABI and physical examination.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Moore, Ph.D.
Organizational Affiliation
LifeNet Health, Scientific Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Institute for Advanced Wound Care
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
ILD Research Center
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Center for Clinical Research
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Limb Preservation Platform
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Limb Preservation Platform
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Facility Name
Fairfield County Foot Surgeons
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Andrews Research and Education Institute
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Rosalind Franklin University, CLEAR
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Facility Name
Boston Medical College
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Wound Institute and Reseach Center
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26933467
Citation
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.
Results Reference
result
PubMed Identifier
28544150
Citation
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.
Results Reference
result

Learn more about this trial

DermACELL in Subjects With Chronic Wounds of the Lower Extremities

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