TY - JOUR
T1 - Cellular versus acellular grafts for diabetic foot ulcers
T2 - Altering the protocol to improve recruitment to a comparative efficacy trial
AU - Tchanque-Fossuo, Catherine N.
AU - Dahle, Sara E.
AU - Lev-Tov, Hadar
AU - Li, Chin Shang
AU - Rivkah Isseroff, R.
N1 - Funding Information:
Drs. Tchanque-Fossuo, Dahle, and Isseroff are from and Dr. Lev-Tov was from the Department of Dermatology, University of California Davis, Sacramento. Drs. Tchanque-Fossuo, Dahle, and Isseroff also are from the VA Northern California Health Care System, Mather. Drs. Tchanque-Fossuo and Isseroff are from the Dermatology Service and Dr. Dahle is from the Podiatry Service. Dr. Lev-Tov currently is from the Department of Dermatology, University of Miami Miller School of Medicine, Florida. Dr. Li is from the Division of Biostatistics, Department of Public Health Sciences, University of California Davis Medical Center. The authors report no conflict of interest. This study was funded by the Veteran’s Administration Merit Award (#10554640), which was awarded to Drs. Dahle and Isseroff. This study was part of a presentation at the 8th Cosmetic Surgery Forum under the direction of Joel Schlessinger, MD; November 30-December 3, 2016; Las Vegas, Nevada. Dr. Tchanque-Fossuo was a Top 10 Fellow and Resident Grant winner. This study was registered at www.clinicaltrials.gov with the identifier NCT01450943. Correspondence: R. Rivkah Isseroff, MD, University of California Davis, Department of Dermatology, 3301 C St, Ste 1400, Sacramento, CA 95816 (rrisseroff@ucdavis.edu).
PY - 2017/11/1
Y1 - 2017/11/1
N2 - 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.
AB - 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.
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M3 - Article
C2 - 29232436
AN - SCOPUS:85041670110
VL - 100
SP - E18-E21
JO - Cutis
JF - Cutis
SN - 0011-4162
IS - 5
ER -