Tallis A, Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB, Collagenase Diabetic Foot Ulcer Study Group., et al.
Clinical therapeutics. Date of publication 2013 Nov 1;volume 35(11):1805-20.
1. Clin Ther. 2013 Nov;35(11):1805-20. doi: 10.1016/j.clinthera.2013.09.013. Epub
2013 Oct 18.
Clinical and economic assessment of diabetic foot ulcer debridement with
collagenase: results of a randomized controlled study.
Tallis A(1), Motley TA, Wunderlich RP, Dickerson JE Jr, Waycaster C, Slade HB;
Collagenase Diabetic Foot Ulcer Study Group.
Collaborators: Tallis A, Motley TT, Wunderlich RP, Sullivan P, Moyer L, Croyle P,
Voigt D.
Author information:
(1)Associated Foot & Ankle Specialists LLC, Phoenix, Arizona.
BACKGROUND: Despite significant advances, the treatment of diabetic foot ulcers
(DFUs) remains a major therapeutic challenge for clinicians, surgeons, and other
health care professionals. There is an urgent need for new strategies with
clinically effective interventions to treat DFUs to reduce the burden of care in
an efficient and cost-effective way.
OBJECTIVE: This randomized trial evaluated and compared the clinical
effectiveness, tolerability, and costs of clostridial collagenase ointment (CCO)
debridement to that of debridement using saline moistened gauze (SMG) and
selective sharp debridement for the treatment of DFUs.
METHODS: Randomized, controlled, parallel group, multicenter, open-label, 12-week
study of 48 patients with neuropathic DFUs randomized to 4 weeks of treatment
with either CCO or SMG after baseline surgical debridement. The primary end point
was the condition of the ulcer bed at the end of treatment as measured using a
standardized wound assessment tool. Secondary end points were the percentage of
reduction in wound area and therapeutic response rates. Adverse events were
monitored for the tolerability analysis. In addition, a comparative
cost-effectiveness analysis was performed from the perspective of the Centers for
Medicare and Medicaid Services as a payer.
RESULTS: Both the CCO and SMG groups had significantly improved wound assessment
scores after 4 weeks of treatment (CCO, -2.5, P = 0.007; SMG, -3.4, P = 0.006).
Only CCO treatment resulted in a statistically significant decrease from baseline
in the mean wound area at the end of treatment (P = 0.0164) and at the end of
follow-up (P = 0.012). In addition, the CCO group exhibited a significantly
better response rate at the end of follow-up compared with the SMG group (0.92 vs
0.75, P < 0.05). Reported adverse events were similar between the 2 treatment
groups. None of the reported adverse events were considered to be related to
treatment. The economic analysis indicated that the direct mean costs per
responder in the physician office setting of care were $832 versus $1042 for the
CCO group versus the SMG group, whereas the direct mean costs per responder in
the hospital outpatient department setting were $1607 versus $1980.
CONCLUSIONS: CCO treatment provides equivalent debridement of DFUs similar to SMG
while fostering better progress toward healing as measured by decreasing wound
area over time and improved response rates at the end of follow-up. In addition,
CCO yields a more favorable cost-effectiveness ratio in both the physician office
and hospital outpatient department settings of care. ClinicalTrials.gov
identifier: NCT01056198.
© 2013 The Authors. Published by Elsevier HS Journals, Inc. All rights reserved.
DOI: 10.1016/j.clinthera.2013.09.013
PMID: 24145042 [Indexed for MEDLINE]
