NCT03414216

Surgical Offloading Procedures for Diabetic Foot Ulcers

Surgical Offloading Procedures for Diabetic Foot Ulcers Compared to Best Non-surgical Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assaf Harofeh MC · Other Government
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

100 consenting subjects with Texas grade 1a diabetic foot ulcers will be randomized to surgical offloading or non-operative offloading.

Detailed description

Background: Diabetic 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 crossover designed RCT. Methods: 100 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 that the non-surgical options available at present. To promote surgery, randomized controlled trial (RCT) level evidence of efficacy is necessary.

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
PROCEDURE	Group 1 early offloading surgery	As above.
PROCEDURE	Group 2 - off-loading in fiberglass cast	As above.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-01-29
• Last updated: 2018-01-29