Trial reportJournal of foot and ankle research2018
Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial.
Trial report in Journal of foot and ankle research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03414216 (Surgical Offloading Procedures for Diabetic Foot Ulcers Compared to Best Non-surgical Treatment), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Surgical Offloading Procedures for Diabetic Foot Ulcers Compared to Best Non-surgical Treatment
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Comparative analysis of surgical and non-surgical wound approaches in diabetic foot ulcer treatment: Meta-analysis and systematic review.International wound journal · 2024Pooled it
- Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review.Diabetes/metabolism research and reviews · 2020Pooled it
- Safety and efficacy of percutaneous toe flexor tenotomies under local anesthesia in an outpatient setting.Journal of orthopaedic surgery and research · 2026Observational
- Optimizing risk management for post-amputation wound complications in diabetic patients: Focus on glycemic and immunosuppressive control.World journal of diabetes · 2025Article
- The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial.Contemporary clinical trials communications · 2023Article
- Effectiveness of Percutaneous Flexor Tenotomies for the Prevention and Management of Toe-Related Diabetic Foot Ulcers: A Systematic Review.Journal of clinical medicine · 2023Review
- Effect of Mini-invasive Floating Metatarsal Osteotomy on Plantar Pressure in Patients With Diabetic Plantar Metatarsal Head Ulcers.Foot & ankle international · 2021Article
- Evaluation of results after distal metatarsal osteotomy by minimal invasive surgery for the treatment of metatarsalgia: patient and anatomical pieces study.Journal of orthopaedic surgery and research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDiabetic foot ulcers are frequently related to elevated pressure under a bony prominence. Conservative treatment includes offloading with orthopaedic shoes and custom made orthotics or plaster casts. While casting in plaster is usually effective in achieving primary closure of foot ulcers, recurrence rates are high. Minimally invasive surgical offloading that includes correction of foot deformities has good short and long term results. The surgery alleviates the pressure under the bony prominence, thus enabling prompt ulcer healing, negating the patient's dependence on expensive shoes and orthotics, with a lower chance of recurrence. The purpose of this protocol is to compare offloading surgery (percutaneous flexor tenotomy, mini-invasive floating metatarsal osteotomy or Keller arthroplasty) to non-surgical treatment for patients with diabetic foot ulcers in a semi-crossover designed RCT.
methodsOne hundred patients with diabetic neuropathy related foot ulcers (tip of toe ulcers, ulcers under metatarsal heads and ulcers under the hallux interphalangeal joint) will be randomized (2:3) to a surgical offloading procedure or best available non-surgical treatment. Group 1 (surgery) will have surgery within 1 week. Group 2 (controls) will be prescribed an offloading cast applied for up to 12 weeks (based on clinical considerations). Following successful offloading treatment (ulcer closure with complete epithelization) patients will be prescribed orthopaedic shoes and custom made orthotics. If offloading by cast for at least 6 weeks fails, or the ulcer recurs, patients will be offered surgical offloading. Follow-up will take place till 2 years following randomization. Outcome criteria will be time to healing of the primary ulcer (complete epithelization), time to healing of surgical wound, recurrence of ulcer, time to recurrence and complications. DISCUSSION: The high recurrence rate of foot ulcers and their dire consequences justify attempts to find better solutions than the non-surgical options available at present. To promote surgery, RCT level evidence of efficacy is necessary.
trial registrationIsrael MOH_2017-08-10_000719. NIH: NCT03414216.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.