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

Abstract

BackgroundApproximately 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.MethodsAdults 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.ResultsThe 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).ConclusionsCCO + 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 registrationThis study was registered at ClinicalTrials.gov as NCT01408277.Electronic supplementary materialThe online version of this article (doi:10.1186/s13047-015-0065-x) contains supplementary material, which is available to authorized users.

Therapeutic Effects of Static Magnetic Field on Wound Healing in Diabetic Rats

“…Impaired wound healing of skin ulcer in diabetic patients is a common, serious and costly global health issue. It is a leading cause of admission, amputation and mortality in diabetic patients [2]. How to accelerate the wound healing in diabetic patients and relieve their suffering has become a great challenge to medical field.…”

Update on management of diabetic foot ulcers

“…Although one study found that CCO is used as management for 17% of DFUs, the evidence for its use is lacking. 33 There are only three RCTs specifically exploring the efficacy of CCO in DFUs. The first was a 12-week parallel multicenter, open-label RCT of 48 patients in 2012, which showed improved healing in the group treated with CCO compared with saline-moistened gauze with selective sharp debridement.…”

Comparative cost and clinical effectiveness of clostridial collagenase ointment for chronic dermal ulcers

“…Cost-effectiveness of CCO in DFU Two cost analyses of CCO debridement in patients with DFU also yielded estimates favoring CCO over alternative debridement methods [40,53]. In an analysis of results from a randomized, open-label trial of 55 patients with DFU using a three-state Markov model, Motley et al calculated that the number of epithelialized weeks was 25% greater in patients treated with the CCO plus serial sharp debridement (35 weeks) versus other debridement methods (28 weeks) [39,53].…”

“…The three health states in the model included inflammation/senescence, granulation/proliferation (patients achieving 100% granulation) and epithelialization, and were based on observed rates from an analysis of patients from the USWR [37]. CCO was the economically dominant strategy, resulting in Reproduced with permission from [53] C Elsevier (2015).…”

“…In an analysis of results from a randomized, open-label trial of 55 patients with DFU using a three-state Markov model, Motley et al calculated that the number of epithelialized weeks was 25% greater in patients treated with the CCO plus serial sharp debridement (35 weeks) versus other debridement methods (28 weeks) [39,53]. Using a 1-year time horizon from a third-party payer perspective, the expected cost per treated DFU was greater for standard DFU care plus serial sharp debridement compared with CCO plus serial sharp debridement: 2376 versus US$2099, respectively ( Figure 5).…”