Surgical Offloading Procedures for Diabetic Foot Ulcers
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|ClinicalTrials.gov Identifier: NCT03414216|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Ulcer||Procedure: Group 1 early offloading surgery Procedure: Group 2 - off-loading in fiberglass cast||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Surgical Offloading Procedures for Diabetic Foot Ulcers Compared to Best Non-surgical Treatment|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Group1 - early off-loading surgery
Within 1 week of randomization, offloading surgery:
Tip of toe ulcers will be treated by percutaneous tenotomy. Ulcers under metatarsal heads will be offloaded with minimally invasive floating metatarsal osteotomy.
Ulcers plantar to the interphalangeal joint of the hallux will be treated by a modified Keller resection arthroplasty.
Procedure: Group 1 early offloading surgery
Active Comparator: Group 2 - off-loading in fiberglass cast
Tip of toe ulcers and ulcers plantar to the interphalangeal joint of the big toe will be casted in a fiberglass cast with a heel, ending under the metatarsal heads, leaving the toes in the air.
Ulcers under metatarsal heads will be casted in a full foot fiberglass cast with a heel with a window below the ulcer designed to relieve pressure under the metatarsal heads.
Procedure: Group 2 - off-loading in fiberglass cast
- Failure to cure [ Time Frame: 12 weeks ]Lack of full epithelization
- Any recurrence of any ulcer at same location [ Time Frame: 2 years ]If either of the outcomes is positive, the case will be counted as a failure.