University of North Texas Health Sciences Center, Bone and Joint Institute, Fort Worth, TX USA.
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.
J Foot Ankle Res. 2015 Feb 28;8:7. doi: 10.1186/s13047-015-0065-x. eCollection 2015.
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.
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.
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).
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.
This study was registered at ClinicalTrials.gov as NCT01408277.
大约 10%-15%的糖尿病患者在其一生中会至少患上一处足部溃疡。治疗糖尿病足溃疡（DFU）会带来巨大的经济负担。梭菌胶原酶软膏（CCO）酶清创可用于清除伤口的坏死组织。本研究旨在评估 CCO 作为一种有效的辅助治疗方法，与连续锐性清创术（SSD）联合使用，并评估与标准 DFU 治疗相比，CCO 在 1 年内的成本效益。
本 12 周、随机、开放标签试验纳入了年龄在 18 岁及以上、患有神经病变性 DFU 的 1 型或 2 型糖尿病患者。患者被随机分配至 CCO+SSD 治疗组或研究者选择的支持性护理+SSD（对照组）。采用从试验中获得的伤口闭合率建立一个 3 状态 Markov 模型，以估计每个患者的愈合伤口周数和预期的 DFU 成本。3 个状态包括未愈合、愈合和死亡。将结果外推至 1 年，以估计每种治疗方法的愈合伤口周数和达到上皮化的平均成本。分析的视角是支付方，即第三方支付方。
研究样本包括 55 名患者（CCO 组 28 名；对照组 27 名）。大多数患者为男性（74.5%），平均年龄为 57.9 岁。与对照组相比，CCO+SSD 组的预计愈合率更高（分别为 89%和 80%）。在 1 年的时间内，CCO+SSD 组积累的上皮化周数比对照组多 25%（分别为 35 周和 28 周）。在 1 年的时间内，对照组的预期 DFU 成本比 CCO 组高（分别为 2376 美元和 2099 美元）。在 1 年的时间内，对照组的溃疡无周成本比 CCO+SSD 组高（分别为 85 美元/闭合伤口周和 61 美元/闭合伤口周）。
CCO+SSD 治疗是一种具有成本效益的 DFU 管理清创方法，能以更低的成本提供更好的结果。需要进一步进行高质量的试验来证实这一发现。
本研究在 ClinicalTrials.gov 注册，编号为 NCT01408277。
