Surgical Offloading Procedures for Diabetic Foot Ulcers

January 26, 2018 updated by: Assaf Harofeh MC

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Single Texas A1 or A2 ulcer.
  • ulcer attributable to an anatomic deformity.

Exclusion Criteria:

  • Unable to understand language of informed consent.
  • Ischemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
As above.
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
As above.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure to cure
Time Frame: 12 weeks
Lack of full epithelization
12 weeks
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf Harofeh MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2019

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 26, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0094-17-ASF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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