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Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers
Published on: March 3, 2023
Complex interventions for preventing diabetic foot ulceration.
Johannes A N Dorresteijn1, Didi M W Kriegsman, Gerlof D Valk
1Department of Internal Medicine, University Medical Center Utrecht, Oudenoord 465, Utrecht, Netherlands, 3513 EP.
Complex interventions combining multiple strategies show limited evidence for preventing diabetic foot ulcers. More high-quality research is needed to determine their effectiveness in reducing amputations.
Area of Science:
- Podiatry
- Diabetology
- Public Health
Background:
- Diabetic foot ulcers are a significant cause of lower limb amputations and economic burden.
- Single preventive strategies have proven insufficient in reducing ulcer incidence.
- Complex interventions integrate multiple strategies targeting patients, healthcare providers, and healthcare structures.
Purpose of the Study:
- To evaluate the effectiveness of complex interventions versus single interventions or usual care for preventing diabetic foot ulcers.
- To assess integrated care approaches combining multiple prevention strategies.
Main Methods:
- Searched multiple databases including Cochrane CENTRAL, MEDLINE, EMBASE, and CINAHL for relevant studies.
- Included prospective randomized controlled trials (RCTs) comparing complex interventions with single interventions or usual care.
- Two independent reviewers selected studies, extracted data, and assessed risk of bias.
Main Results:
- Only five RCTs met inclusion criteria, exhibiting substantial heterogeneity in study design and interventions.
- Education-centered complex interventions showed little benefit compared to usual care or written instructions.
- More intensive complex interventions demonstrated potential, with one study reporting improved self-care and another a significant, cost-effective reduction in amputations (RR 0.30).
- All included RCTs were assessed as having a high risk of bias.
Conclusions:
- High-quality evidence evaluating complex interventions for diabetic foot ulcer prevention is lacking.
- Insufficient evidence currently supports the benefit of complex interventions in this area.
- Further rigorous research is required to establish the efficacy of these integrated approaches.
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