The Use of Bioscaffolds in Conjunction With Negative Pressure Therapy: A Prospective Randomized Double-Blinded Trial

NCT01228500 | Withdrawn DMC

• 1 other identifier: TEI-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Ulcer, Diabetic

Outcome Measures

Primary Outcomes (1)

• Time to healing

  12 weeks

Study Arms (1)

Experimental Arm (Internal Control)

EXPERIMENTAL

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

Interventions

PriMatrix DEVICE

Dermal Repair Scaffold

Experimental Arm (Internal Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Jeremy Cook, DPM

  Beth Israel Deaconess Medical Center, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)