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Efficacy of Cellular Therapy for Diabetic Foot Ulcer: A Meta-Analysis of Randomized Controlled Clinical Trials
Ye Zhang1, Hong Deng1, Zhouping Tang1
11 Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Abstract:
Diabetes mellitus is a widely spread chronic disease with growing incidence worldwide, and diabetic foot ulcer is one of the most serious complications of diabetes. Cellular therapy has shown promise in the management of diabetic foot ulcer in many preclinical experiments and clinical researches. Here, we performed a meta-analysis to evaluate the efficacy and safety of cellular therapy in the management of diabetic foot ulcer. We systematically searched PubMed, MEDLINE, EMBASE, and Cochrane Library databases from inception to May 2017 for randomized controlled trials assessing the efficacy of cellular therapy in diabetic foot ulcer, and a meta-analysis was conducted. A total of 6 randomized controlled clinical trials involving 241 individuals were included in this meta-analysis. The results suggested that cellular therapy could help accelerating the healing of diabetic foot ulcer, presented as higher ankle-brachial index (mean difference = 0.17, 95% confidence interval [CI] = 0.11 to 0.23), higher transcutaneous oxygen pressure (standardized mean difference [SMD] = 1.43; 95% CI, 1.09- to 1.78), higher ulcer healing rate (relative risk [RR] = 1.78; 95% CI, 1.41 to 2.25), higher amputation-free survival (RR = 1.25; 95% CI, 1.11 to 1.40), and lower scale of pain (SMD = -1.69; 95% CI, -2.05 to -1.33). Furthermore, cellular therapy seemed to be safe, with no serious complications and low risk of short-term slight complications. Cellular therapy could accelerate the rate of diabetic foot ulcer healing and may be more efficient than standard therapy for diabetic foot treatment.
Insights
Cellular therapy significantly accelerates diabetic foot ulcer healing and improves patient outcomes. This safe treatment enhances healing rates, reduces pain, and lowers amputation risk compared to standard care.
Area of Science:
- Regenerative Medicine
- Diabetology
- Wound Healing Research
Background:
- Diabetic foot ulcer (DFU) is a severe complication of diabetes mellitus, posing a significant global health challenge.
- Existing treatments for DFU have limitations, highlighting the need for novel therapeutic approaches.
- Cellular therapy has emerged as a promising strategy for DFU management, supported by preclinical and clinical evidence.
Purpose of the Study:
- To conduct a meta-analysis evaluating the efficacy and safety of cellular therapy in managing diabetic foot ulcers.
- To synthesize data from randomized controlled trials (RCTs) to provide a comprehensive assessment of cellular therapy's impact on DFU healing.
Main Methods:
- Systematic literature search of PubMed, MEDLINE, EMBASE, and Cochrane Library databases up to May 2017.
- Inclusion of 6 randomized controlled trials involving 241 participants.
- Meta-analysis to quantify the effects of cellular therapy on key DFU healing parameters.
Main Results:
- Cellular therapy demonstrated significant improvements in healing metrics, including higher ankle-brachial index (MD = 0.17) and transcutaneous oxygen pressure (SMD = 1.43).
- Higher ulcer healing rates (RR = 1.78), improved amputation-free survival (RR = 1.25), and reduced pain scores (SMD = -1.69) were observed.
- The therapy was found to be safe, with no serious adverse events and a low incidence of minor short-term complications.
Conclusions:
- Cellular therapy effectively accelerates the healing process of diabetic foot ulcers.
- It offers superior outcomes compared to standard therapy for diabetic foot treatment.
- The safety profile supports its consideration as a viable therapeutic option for DFU.
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