The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial
This study is currently recruiting participants.
Verified June 2012 by TEI Biosciences Inc.
Sponsor:
TEI Biosciences Inc.
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by:
TEI Biosciences Inc.
ClinicalTrials.gov Identifier:
NCT01228500
First received: October 25, 2010
Last updated: June 4, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Foot Ulcer, Diabetic |
Device: PriMatrix |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial |
Resource links provided by NLM:
Further study details as provided by TEI Biosciences Inc.:
Primary Outcome Measures:
- Time to healing [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Experimental Arm (Internal Control)
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 |
Device: PriMatrix
Dermal Repair Scaffold
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228500
Contacts
| Contact: Jeremy Cook, DPM | 781-767-1923 |
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Jeremy Cook, DPM 781-767-1923 | |
| Principal Investigator: Emily Cook, DPM | |
Sponsors and Collaborators
TEI Biosciences Inc.
Beth Israel Deaconess Medical Center
Investigators
| Principal Investigator: | Jeremy Cook, DPM | Beth Israel Deaconess Medical Center, Harvard Medical School |
More Information
No publications provided
| Responsible Party: | Yiannis Monovoukas, TEI Biosciences Inc. |
| ClinicalTrials.gov Identifier: | NCT01228500 History of Changes |
| Other Study ID Numbers: | TEI-001 |
| Study First Received: | October 25, 2010 |
| Last Updated: | June 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Foot Ulcer Diabetic Foot Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases Diabetic Neuropathies |
ClinicalTrials.gov processed this record on June 18, 2013