Jimenez JC, Agnew PS, Mayer P, Clements JR, Caporusso JM, Lange DL, Dickerson JE Jr, Slade HB, et al.
Wounds : a compendium of clinical research and practice. Date of publication 2017 Feb 27;volume ():.
1. Wounds. 2017 Feb 27. pii: WNDS20170227-2. [Epub ahead of print]
Enzymatic Debridement of Chronic Nonischemic Diabetic Foot Ulcers: Results of a
Randomized, Controlled Trial.
Jimenez JC(1), Agnew PS(2), Mayer P(3), Clements JR(4), Caporusso JM(5), Lange
DL(6), Dickerson JE Jr(7), Slade HB(8).
Author information:
(1)UCLA Medical Center, Sylmar, CA.
(2)Coastal Podiatry Inc, Virginia Beach, VA.
(3)The Mayer Institute, Hamilton, Ontario, Canada.
(4)Carilion Clinic, Roanoke, VA.
(5)Complete Family Foot Care, McAllen, TX.
(6)Smith & Nephew Inc, Fort Worth, TX.
(7)Smith & Nephew Inc, Fort Worth, TX and Graduate School of Biomedical Sciences,
University of North Texas Health Science Center, Fort Worth, TX.
(8)Smith & Nephew Inc, Fort Worth, TX andDepartment of Pediatrics, University of
North Texas Health Science Center.
OBJECTIVE: The aim of this randomized, controlled multicenter trial was to
evaluate the clinical outcomes associated with the use of clostridial collagenase
ointment (CCO) for up to 12 weeks in 215 patients with type 1 or type 2 diabetes
mellitus and a neuropathic, nonischemic diabetic foot ulcer (DFU).
MATERIALS AND METHODS: Patients were randomized into either a group receiving CCO
applied once daily at a thickness of ~2 mm or a group receiving standard care
(SC) consisting of a daily application of a hydrogel as needed to maintain a
moist ulcer environment. All ulcers were covered with a nonadherent foam dressing
that was changed once daily, and sharp debridement was allowed when the
investigators deemed it medically warranted. Outcome measures included the
percent change in ulcer area and the effect of baseline wound microbiota on
subsequent healing. Patients with ulcers that showed no decrease in size after 4
weeks were crossed over to the other treatment group.
RESULTS: The wound area decreased relative to baseline for both the CCO group
(-60%, P < .0001; -65%, P < .0001) and the control group (-50%, P = .0001; -51%,
P = .0001) after 6 and 12 weeks, respectively. While the intergroup differences
at 6 and 12 weeks did not reach statistical significance (P = .3801; P = .3606),
mean percent reductions for the CCO group were greater than the control at all 12
time points (averages: -55%; -41%, respectively). Overall closure rate was 21%
and 41% (weeks 6 and 12, P = .3705; P = .2358) with no significant differences
between groups. However, the DFUs that showed no improvement at 4 weeks (N = 24,
12/group) were crossed over to the other treatment group. A numerically greater
proportion of subjects who switched to CCO achieved closure (33%) than for those
who switched to SC (8%). Baseline biopsy showed that despite the absence of
clinical signs of infection, all ulcers were heavily colonized by 1 to 5 species
of bacteria. No adverse events were assessed by the investigators as related to
either treatment.
CONCLUSION: These results confirm observations from previous studies
demonstrating positive outcomes associated with enzymatic debridement with CCO
following 6 weeks of treatment.
PMID: 28267678
