Surgical Offloading Procedures for Diabetic Foot Ulcers

NCT03414216 | Unknown

• 1 other identifier: 0094-17-ASF
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (2)

• Failure to cure

  Lack of full epithelization

  12 weeks

• 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

Study Arms (2)

Group1 - early off-loading surgery

EXPERIMENTAL

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

Group 2 - off-loading in fiberglass cast

ACTIVE COMPARATOR

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

Interventions

Group 1 early offloading surgery PROCEDURE

As above.

Group1 - early off-loading surgery

Group 2 - off-loading in fiberglass cast PROCEDURE

As above.

Group 2 - off-loading in fiberglass cast

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assaf Harofeh MC: lead

Related Publications (1)

• Finestone AS, Tamir E, Ron G, Wiser I, Agar G. Surgical offloading procedures for diabetic foot ulcers compared to best non-surgical treatment: a study protocol for a randomized controlled trial. J Foot Ankle Res. 2018 Feb 20;11:6. doi: 10.1186/s13047-018-0248-3. eCollection 2018.

  PMID: 29467829 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Casts, Surgical

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Orthopaedic Surgeon

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 29, 2018
• Study Start: March 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 29, 2018

Record last verified: 2018-01