Motley TA, Gilligan AM, Lange DL, Waycaster CR, Dickerson JE Jr, et al.
Journal of foot and ankle research. Date of publication 2015 Feb 28;volume 8():7.
1. J Foot Ankle Res. 2015 Feb 28;8:7. doi: 10.1186/s13047-015-0065-x. eCollection
2015.
Cost-effectiveness of clostridial collagenase ointment on wound closure in
patients with diabetic foot ulcers: economic analysis of results from a
multicenter, randomized, open-label trial.
Motley TA(1), Gilligan AM(2), Lange DL(3), Waycaster CR(2), Dickerson JE Jr(4).
Author information:
(1)University of North Texas Health Sciences Center, Bone and Joint Institute,
Fort Worth, TX USA.
(2)Smith & Nephew Inc., 3909 Hulen Street, Fort Worth, TX 76107 USA ; Department
of Pharmacotherapy, University of North Texas Health Sciences Center, Fort Worth,
TX USA.
(3)Smith & Nephew Inc., 3909 Hulen Street, Fort Worth, TX 76107 USA ; Department
of Cell Biology and Anatomy, University of North Texas Health Sciences Center,
Fort Worth, TX USA.
(4)Smith & Nephew Inc., 3909 Hulen Street, Fort Worth, TX 76107 USA ; Department
of Pediatrics, University of North Texas Health Sciences Center, Fort Worth, TX
USA.
Erratum in
J Foot Ankle Res. 2016;9:28.
BACKGROUND: Approximately 10%-15% of people with diabetes develop at least one
foot ulcer during their lifetime. Treatment of diabetic foot ulcers (DFUs)
represents a significant economic burden. Enzymatic debridement with clostridial
collagenase ointment (CCO) can be used to remove necrotic tissue from wounds.
This study examined the impact of CCO as an effective adjunct therapy to serial
sharp debridement (SSD) and assessed the cost-effectiveness of CCO compared with
standard DFU treatments over 1 year.
METHODS: Adults 18 years or older with a diagnosis of type 1 or type 2 diabetes
who had a neuropathic DFU were enrolled in a 12-week, randomized, open-label
trial. Patients were randomly assigned to either treatment with CCO + SSD or to
investigator-selected supportive care + SSD (Control). A 3-state Markov model
with a 1-week cycle length was developed using wound-closure rates from the trial
to estimate the number of healed-wound weeks and the expected DFU cost per
patient. The 3 states included unhealed, healed, and death. Results were
extrapolated to 1 year to estimate the number of healed-wound weeks per treatment
and the average cost to achieve epithelialization. The perspective of the
analysis was that of the payer, specifically, the third party payer.
RESULTS: The study sample included 55 patients (28 in CCO group; 27 Control). The
majority were men (74.5%) with a mean age of 57.9 years. Projected healing rates
were greater for the CCO + SSD group compared to Control (89% vs. 80%,
respectively). The expected number of epithelialized weeks accumulated over
1 year was 25% greater in the CCO + SSD group than for Control (35 vs. 28 weeks,
respectively). Over a 1-year time horizon, the expected cost per DFU was greater
in the Control group than the CCO group ($2,376 vs. $2,099, respectively). The
estimated cost per ulcer-free week was 40% higher for Control ($85/closed-wound
week) than for CCO + SSD ($61/closed-wound week).
CONCLUSIONS: CCO + SSD therapy is a cost-effective method of debridement in the
management of patients with DFUs, providing better outcomes at a lower cost.
Further high quality trials are needed to confirm this finding.
TRIAL REGISTRATION: This study was registered at ClinicalTrials.gov as
NCT01408277.
DOI: 10.1186/s13047-015-0065-x
PMCID: PMC4357050
PMID: 25767565
