Motley TA, Lange DL, Dickerson JE Jr, Slade HB, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2014 Mar 1;volume 26(3):57-64.
1. Wounds. 2014 Mar;26(3):57-64.
Clinical outcomes associated with serial sharp debridement of diabetic foot
ulcers with and without clostridial collagenase ointment.
Motley TA(1), Lange DL(2), Dickerson JE Jr(3), Slade HB(4).
Author information:
(1)Department of Orthopaedics, University of North Texas Health Science Center,
Fort Worth, TX;
(2)Smith & Nephew Biotherapeutics, Fort Worth, TX.
(3)Smith & Nephew Biotherapeutics, Fort Worth, TX; and Department of Cell Biology
and Anatomy,University of North Texas Health Science Center, Fort Worth, TX;
email: jaime.dickerson@smith-nephew.com.
(4)Smith & Nephew Biotherapeutics, Fort Worth, TX; and Department of Pediatrics,
University of North Texas Health Science Center, Fort Worth, TX.
OBJECTIVE: Fifty-five subjects with diabetes mellitus type 1 or 2 and a
neuropathic, nonischemic foot ulcer were enrolled into this randomized,
controlled, multicenter trial designed to examine the effects of debridement with
clostridial collagenase ointment (CCO) used in conjunction with serial sharp
debridement for a period of 6 weeks.
METHODS: Serial sharp debridement without adjunctive CCO was used in the control
group. Various standard care therapies thought to support debridement by
endogenous proteases were selected at the discretion of the investigators for use
in the control group. The primary outcome measure of this trial was the percent
change in ulcer area from baseline at the end of the debridement/treatment period
(EOT) and at the end of an additional 6 weeks of follow-up (EOS). Secondary
objectives were to assess wound status at EOT and EOS using a standardized wound
assessment tool, and to compare the average time to closure for ulcers debrided
with serial sharp debridement with and without adjunctive CCO.
RESULTS: Wound area decreased relative to baseline for both the CCO group (-68%,
-61%) and the control group (-36%, -46%) at EOT and EOS, respectively. While the
inter-group differences did not reach statistical significance, wound area was
significantly decreased from baseline at both EOT and EOS for the CCO (P < 0.001)
but not for the control group. Wound status scores (scale range 8 to 40) improved
for both groups during treatment (CCO: -3.5, control: -3.2) and follow-up (CCO:
-5.3, control: -6.4). No differences were observed in the number of sharp
debridements (CCO: 3.7, control: 4.0). Median time to closure for wounds that
healed was 6 weeks for CCO and 8 weeks for control. On average, ulcers treated
with serial sharp debridement plus adjunctive CCO decreased in size more rapidly
than ulcers treated without adjunctive CCO debridement. No safety issues were
identified based on a review of reported adverse events.
CONCLUSION: These results suggest there is more to wound debridement than meets
the eye, and establish a foundation for larger, confirmatory studies.
PMID: 25860329
