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 language | English (US) |
|---|---|
| Pages (from-to) | E18-E21 |
| Journal | Cutis |
| Volume | 100 |
| Issue number | 5 |
| State | Published - Nov 1 2017 |
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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; Rivkah Isseroff, R.
In: Cutis, Vol. 100, No. 5, 01.11.2017, p. E18-E21.Research output: Contribution to journal › Article
}
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.
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 -