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A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

Primary Purpose

Foot Ulcer, Diabetic

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MatriStem
Cellular Dermal Replacement Tissue
Sponsored by
Integra LifeSciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foot Ulcer, Diabetic

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Major Inclusion Criteria:

  • Subject has a current diagnosis of type I or type II diabetes
  • Subject's ulcer is on the forefoot or heel
  • Subject has chronic ulcer - has been present for minimum of 4 weeks
  • Subject's ulcer extends through the dermis and into the subcutaneous tissue
  • Subject's HgbA1c <12%
  • Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest

Major Exclusion Criteria:

  • Subject has a known sensitivity to bovine- or porcine-derived products.
  • Subject's ulcer is due to a non-diabetic etiology
  • Subject's ulcer is over a Charcot deformity of the mid-foot
  • Subject's random blood sugar readings are >450 mg/dL
  • Subject is on dialysis
  • Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer

Sites / Locations

  • Carl t. Hayden Phoenix VA Medical Center
  • Associated Foot & Ankle Specialists, PC
  • Center for Clinical Research Inc.
  • Valley Vascular Surgery Associates
  • Denver VA Medical Center
  • Georgetown University Medical Center
  • Advanced Research Institute of Miami
  • NewPhase Clinical Trials, Corp.
  • Professional Health Care of Pinellas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Comparator

Arm Description

MatriStem MicroMatrix and MatriStem Wound Matrix

Cellular Dermal Replacement Tissue

Outcomes

Primary Outcome Measures

Number of Participants With Complete Wound Closure
Number of participants with incidence of complete wound closure

Secondary Outcome Measures

Full Information

First Posted
May 17, 2013
Last Updated
March 19, 2021
Sponsor
Integra LifeSciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01858545
Brief Title
A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers
Official Title
An Evaluation of Tissue Engineering Approaches for Treatment of Neuropathic Diabetic Foot Ulcers Resistant to Standard of Care: A Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to assess the effectiveness of MatriStem devices compared to cellular dermal replacement tissue, for the treatment of non-healing diabetic foot ulcers.
Detailed Description
Due to their characteristically poor healing capacity, diabetic foot ulcers (DFUs) are challenging for clinicians to treat. This prospective, multi-center clinical study will examine outcomes following treatment of DFUs, with one of two FDA cleared tissue-engineered devices, MatriStem® or cellular dermal replacement tissue, on DFUs that have demonstrated an inadequate response to initial standard of care therapy. The incidence of ulcer closure, rate of wound closure, and quality of life will be evaluated over a eight week period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
MatriStem MicroMatrix and MatriStem Wound Matrix
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Cellular Dermal Replacement Tissue
Intervention Type
Device
Intervention Name(s)
MatriStem
Intervention Description
MatriStem MicroMatrix and MatriStem Wound Matrix
Intervention Type
Device
Intervention Name(s)
Cellular Dermal Replacement Tissue
Intervention Description
Cellular Dermal Replacement Tissue
Primary Outcome Measure Information:
Title
Number of Participants With Complete Wound Closure
Description
Number of participants with incidence of complete wound closure
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Major Inclusion Criteria: Subject has a current diagnosis of type I or type II diabetes Subject's ulcer is on the forefoot or heel Subject has chronic ulcer - has been present for minimum of 4 weeks Subject's ulcer extends through the dermis and into the subcutaneous tissue Subject's HgbA1c <12% Subject has adequate circulation to the study foot as evidenced by a Doppler measured ABI greater than or equal to 0.7after 10 minutes rest Major Exclusion Criteria: Subject has a known sensitivity to bovine- or porcine-derived products. Subject's ulcer is due to a non-diabetic etiology Subject's ulcer is over a Charcot deformity of the mid-foot Subject's random blood sugar readings are >450 mg/dL Subject is on dialysis Subject has a non-study ulcer on the study limb located within 7.0 cm of the study ulcer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Gilbert, PhD
Organizational Affiliation
Integra LifeSciences
Official's Role
Study Director
Facility Information:
Facility Name
Carl t. Hayden Phoenix VA Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Associated Foot & Ankle Specialists, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Center for Clinical Research Inc.
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Vascular Surgery Associates
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Denver VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Advanced Research Institute of Miami
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
NewPhase Clinical Trials, Corp.
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Professional Health Care of Pinellas
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers

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