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:
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
  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 April 16, 2014