Cellular versus acellular grafts for diabetic foot ulcers

Altering the protocol to improve recruitment to a comparative efficacy trial

Catherine N. Tchanque-Fossuo, Sara E. Dahle, Hadar Lev-Tov, Chin-Shang Li, Roslyn Rivkah Isseroff

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Diabetic foot ulcers (DFUs) have a substantial impact on public health. The standard of care (SOC) for DFUs consists of a multi-disciplinary approach involving glycemic control, wound care with debridement of necrotic tissue, application of a moist dressing, infection control, use of off-loading devices, and patient education. New therapeutic devices aim to target the extracellular matrix (ECM) that is impaired in DFU; however, there is insufficient data on the effectiveness of such therapies along with lack of evidence on their long-term effectiveness. We hypothesized that there is no differ-ence in healing between the cellular matrix and an acellular matrix relative to SOC. To test this hypothesis, we conducted a randomized, single-blind clinical trial in patients with nonhealing DFUs that included 3 treatment arms: (1) SOC, (2) SOC plus a bioengineered ECM with living fibroblasts, and (3) SOC plus a bioengineered ECM devoid of cells. Our trial currently is closed for enrollment, as we have reached our target population size. Amendments to the protocol were made to help reach this threshold.

Original languageEnglish (US)
Pages (from-to)E18-E21
JournalCutis
Volume100
Issue number5
StatePublished - Nov 1 2017

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Diabetic Foot
Standard of Care
Transplants
Extracellular Matrix
Equipment and Supplies
Health Services Needs and Demand
Debridement
Patient Education
Bandages
Infection Control
Population Density
Arm
Therapeutics
Public Health
Fibroblasts
Clinical Trials
Wounds and Injuries

ASJC Scopus subject areas

  • Dermatology

Cite this

Cellular versus acellular grafts for diabetic foot ulcers : Altering the protocol to improve recruitment to a comparative efficacy trial. / Tchanque-Fossuo, Catherine N.; Dahle, Sara E.; Lev-Tov, Hadar; Li, Chin-Shang; Isseroff, Roslyn Rivkah.

In: Cutis, Vol. 100, No. 5, 01.11.2017, p. E18-E21.

Research output: Contribution to journalArticle

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