Institution for Clinical Sciences in Lund, Lund University, Sweden.
Diabetologia. 2011 Jan;54(1):65-8. doi: 10.1007/s00125-010-1946-y. Epub 2010 Oct 19.
AIMS/HYPOTHESIS: The randomised, double-blind, placebo-controlled Hyperbaric Oxygen Therapy (HBOT) in Diabetic Patients with Chronic Foot Ulcers (HODFU) study showed beneficial effect of HBOT. As this treatment is expensive and time-consuming, being able to select patients for therapy would be very useful. The aim of this study was to evaluate whether circulatory variables could help in predicting outcome of HBOT.
All HODFU study participants who completed therapy, predefined as receiving at least 36 out of 40 scheduled HBOT/placebo sessions, were included in this study (n = 75). Baseline transcutaneous oximetry (TcPO₂), toe blood pressure (TBP) and ankle-brachial index (ABI) were measured. Ulcer healing rate was registered at the 9-month follow-up visit. An ulcer was considered healed when it was completely epithelialised and remained so at the 12-month follow-up.
In the HBOT group TcPO₂ were significantly lower for patients whose ulcer did not heal as compared with those whose ulcers healed. A significantly increased healing frequency was seen with increasing TcPO(2) levels in the HBOT group (TcPO₂/healing rate: <25 mmHg/0%; 26-50 mmHg/50%; 51-75 mmHg/73%; and >75 mmHg/100%). No statistically significant relation between the level of TBP or ABI and healing frequency was seen.
CONCLUSIONS/INTERPRETATION: Our results indicate that TcPO₂ in contrast to ABI and TBP correlates to ulcer healing following HBOT. We suggest HBOT as a feasible adjunctive treatment modality in diabetic patients with chronic non-healing foot ulcers when basal TcPO₂ at the dorsum of the foot is above 25 mmHg.
NCT00953186
Mrs Thelma Zoegas Foundation and Faculty of Medicine, Lund University.
目的/假设：随机、双盲、安慰剂对照的高压氧治疗（HBOT）糖尿病慢性足部溃疡（HODFU）研究显示 HBOT 有益。由于这种治疗既昂贵又耗时，如果能够选择适合治疗的患者将非常有用。本研究旨在评估循环变量是否有助于预测 HBOT 的治疗效果。
所有完成治疗的 HODFU 研究参与者（定义为至少接受了 40 次预定的 HBOT/安慰剂治疗中的 36 次）均纳入本研究（n=75）。测量基线经皮氧分压（TcPO₂）、脚趾血压（TBP）和踝肱指数（ABI）。在 9 个月的随访时记录溃疡愈合率。当溃疡完全上皮化且在 12 个月的随访时仍然如此时，认为溃疡已愈合。
与溃疡未愈合的患者相比，HBOT 组 TcPO₂ 较低的患者的溃疡愈合率明显更高。HBOT 组 TcPO₂ 水平升高与愈合频率增加呈显著相关（TcPO₂/愈合率：<25mmHg/0%；26-50mmHg/50%；51-75mmHg/73%；>75mmHg/100%）。在 TBP 或 ABI 水平与愈合频率之间未观察到统计学显著关系。
结论/解释：我们的结果表明，与 ABI 和 TBP 相比，TcPO₂ 与 HBOT 治疗后的溃疡愈合相关。当足部背侧的基础 TcPO₂ 高于 25mmHg 时，我们建议将 HBOT 作为糖尿病慢性不愈合足部溃疡患者的一种可行的辅助治疗方法。
NCT00953186
Thelma Zoegas 夫人基金会和隆德大学医学院。
