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.DiscussionThe 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.
Highlights
Diabetic foot ulcers are frequently related to elevated pressure under a bony prominence
The procedure had negative implications on the foot biomechanics and possibly a slight decrease in overall function as assessed by SF36 [24, 25]. Another randomized control trial (RCT) compared the effect of debridement, removal of bone segments underlying the lesions and surgical closure compared with conservative treatment for offloading diabetic ulcers [26]
While preventive medicine is usually considered to be a superior approach to treating disease already manifested, little research has been invested in diabetic foot ulcers (DFU) prevention [41]
Summary
Study design is according to CONSORT guidelines. Patients with a Texas stage A, grade 1 or 2 diabetic-neuropathic ulcer attributable to an anatomical deformity, examined at a foot and ankle outpatient clinic specializing in the treatment of diabetic foot ulcers will be approached to take part in a semi-crossover designed RCT assessing the efficacy of the surgery in healing the ulcer and preventing its recurrence. If the ulcer is not healing with non-surgical treatment, or has not healed completely at 12 weeks, the patient will be offered surgery. Follow-up will take place at weeks 1, 2, 4 and 6 after surgery, and weekly during non-surgical treatment up to complete wound closure or up to 12 weeks. Group 2a will include all patients randomized to cast offloading that completed at least 6 weeks of treatment or had complete ulcer healing. Group 2b will include patients randomized to cast offloading that failed to complete 6 weeks of cast offloading due to complications or lack of compliance. Failure will be defined as a composite of lack of complete closure at 12 weeks or recurrence within 2 years from surgery. Outcome measures will include time to ulcer healing (complete epithelization) time to surgical wound healing, ulcer length, width & depth, complications and recurrence. Our calculations are based on the clinical data in our clinic, different from those presented by Armstrong et al e.g. for recurrence [13]
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