Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial.
Abstract
Background Diabetic foot wounds, particularly those secondary to amputation, are very complex and difficult to treat. We investigated whether negative pressure wound therapy (NPWT) improves the proportion and rate of wound healing after partial foot amputation in patients with diabetes.Methods We enrolled 162 patients into a 16-week, 18-centre, randomised clinical trial in the USA. Inclusion criteria consisted of partial foot amputation wounds up to the transmetatarsal level and evidence of adequate perfusion. Patients who were randomly assigned to NPWT (n=77) received treatment with dressing changes every 48 h. Control patients (n=85) received standard moist wound care according to consensus guidelines. NPWT was delivered through the Vacuum Assisted Closure (VAC) Therapy System. Wounds were treated until healing or completion of the 112-day period of active treatment. Analysis was by intention to treat. This study has been registered with , number NCT00224796.Findings More patients healed in the NPWT group than in the control group (43 [56%] vs 33 [39%], p=0.040). The rate of wound healing, based on the time to complete closure, was faster in the NPWT group than in controls (p=0.005). The rate of granulation tissue formation, based on the time to 76-100% formation in the wound bed, was faster in the NPWT group than in controls (p=0.002). The frequency and severity of adverse events (of which the most common was wound infection) were similar in both treatment groups.Interpretation NPWT delivered by the VAC Therapy System seems to be a safe and effective treatment for complex diabetic foot wounds, and could lead to a higher proportion of healed wounds, faster healing rates, and potentially fewer re-amputations than standard care.
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In a meta-analysis of 11 multicenter randomized clinical trials of 655 participants with noninfected, nonischemic diabetic foot ulcers, patients receiving placenta-derived products had a higher incidence of complete resolution of diabetic foot ulcer at 12 to 16 weeks than those with similar care and an alginate or foam control dressing (66.9% vs 34.1%; RR, 2.0; 95% CI, 1.67-2.39).
“In a meta-analysis of 11 multicenter randomized clinical trials of 655 participants with noninfected, nonischemic diabetic foot ulcers, patients receiving placenta-derived products had a higher incidence of complete resolution of diabetic foot ulcer at 12 to 16 weeks than those with similar care and an alginate or foam control dressing (66.9% vs 34.1%; RR, 2.0; 95% CI, 1.67-2.39;P < .001).68”
From Diabetic Foot Ulcers (2023) · cites this paper as [68]
Placenta-derived products have a higher likelihood of complete healing at 12-16 wk compared with control dressing (relative risk, 2.0; 95% CI, 1.67-2.39; P < .001), based on a meta-analysis of 11 multicenter randomized clinical trials involving 655 people with diabetic foot ulcers.
“Placenta-derived products Contain growth factors, collagen-rich extracellular matrix, and cells that might accelerate wound healing Higher likelihood of complete healing at 12-16 wk compared with control dressing (relative risk, 2.0; 95% CI, 1.67-2.39;P < .001).[66][67][68] Data from a meta-analysis of 11 multicenter randomized clinical trials involving 655 people with diabetic foot ulcers.”
From Diabetic Foot Ulcers (2023) · cites this paper as [68]
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- Authors
- Armstrong, D. G., & Lavery, L. A.
- Affiliations
- Rosalind Franklin University of Medicine and Science (US)
- Texas A&M University (US)
- Corresponding author
- Armstrong, David G
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2005-11
- Volume
- 366
- Issue
- 9498
- Pages
- 1704-1710
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2148759729
- Cited by
- 963
- References
- 41
- Citations by year
- 2026: 30 · 2025: 44 · 2024: 41 · 2023: 19 · 2022: 32 · 2021: 36 · 2020: 52 · 2019: 34 · 2018: 48 · 2017: 31 · 2016: 52 · 2015: 56 · 2014: 62 · 2013: 69 · 2012: 68
- FWCI
- 27.11
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Kinetic Concepts
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetic Foot Ulcer Assessment and Management
- Health Sciences › Medicine › Rehabilitation › Wound Healing and Treatments
- Health Sciences › Medicine › Surgery › Surgical site infection prevention
- Keywords
- negative pressure wound therapy, diabetic foot, partial foot amputation, wound healing, granulation tissue formation, wound infection, diabetes mellitus
- MeSH terms
- Air Pressure, Amputation, Surgical, Female, Humans, Male, Middle Aged, Reoperation, Vacuum, Wound Healing, Wounds and Injuries, Diabetic Foot
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