Back to resultsThe Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
Primary Purpose
Foot Ulcer, Diabetic
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PriMatrix
Sponsored by
About this trial
This is an interventional treatment trial for Foot Ulcer, Diabetic
Eligibility Criteria
Inclusion Criteria:
- Adult Type 1 or 2 diabetic patients that present with foot ulcers.
- Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
- Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
- Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
- All ulcer durations will be eligible
- Patients currently receiving NPWT for a diabetic foot ulcer
- Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.
Exclusion Criteria:
- Active foot infections
- Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
- Patients who are pregnant
- Allergies to any material contained within the NPWT or bioscaffold
- Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Arm (Internal Control)
Arm Description
One-half of ulcer receives negative pressure wound therapy One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy
Outcomes
Primary Outcome Measures
Time to healing
Secondary Outcome Measures
Full Information
NCT ID
NCT01228500
First Posted
October 25, 2010
Last Updated
May 15, 2016
Sponsor
Integra LifeSciences Corporation
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01228500
Brief Title
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
Official Title
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary aim of this study proposal is to test an innovative form of fetal bovine dermis bioscaffold in combination with negative pressure wound therapy (NPWT) to enhance wound healing in diabetic foot ulcers.
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
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm (Internal Control)
Arm Type
Experimental
Arm Description
One-half of ulcer receives negative pressure wound therapy
One-half of ulcer receives a fetal bovine collagen bioscaffold (PriMatrix, TEI Biosciences, Boston, MA) in addition to the same negative pressure wound therapy
Intervention Type
Device
Intervention Name(s)
PriMatrix
Intervention Description
Dermal Repair Scaffold
Primary Outcome Measure Information:
Title
Time to healing
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult Type 1 or 2 diabetic patients that present with foot ulcers.
Ulcer size of at least 3 centimeters (cm) in diameter at its widest dimension.
Ulcer depth: Full thickness (absence of all epithelial layers or deeper)
Adequate perfusion (at least one palpable pedal pulse or pedal bypass graft)
All ulcer durations will be eligible
Patients currently receiving NPWT for a diabetic foot ulcer
Patients must be appropriate NPWT candidates and be willing and able to sleep, ambulate, and rest with the NPWT unit in place.
Exclusion Criteria:
Active foot infections
Presence of any serious disease including end-stage renal failure requiring dialysis or renal transplantation or active malignant disease requiring treatment which seriously compromises the patient's ability to complete this study
Patients who are pregnant
Allergies to any material contained within the NPWT or bioscaffold
Any condition that would exclude NPWT use including but not limited to active bleeding, presence of malignancy in the wound or inability to follow any of the NPWT safety guidelines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Cook, DPM
Organizational Affiliation
Beth Israel Deaconess Medical Center, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
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