Surgical Offloading Procedures for Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03414216
• Other study ID #: 0094-17-ASF
• Status: Not yet recruiting
• Phase: N/A
• First received: December 22, 2017
• Last updated: January 26, 2018
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2018
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Single Texas A1 or A2 ulcer.

• ulcer attributable to an anatomic deformity.

Exclusion Criteria:

• Unable to understand language of informed consent.

• Ischemia.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Procedure:
• Group 1 early offloading surgery
As above.
• Group 2 - off-loading in fiberglass cast
As above.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assaf Harofeh MC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure to cure	Lack of full epithelization	12 weeks
Primary	Any recurrence of any ulcer at same location	If either of the outcomes is positive, the case will be counted as a failure.	2 years