Surgical Offloading Procedures for Diabetic Foot Ulcers

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03414216
Study type	Interventional
Source	Assaf-Harofeh Medical Center
Contact
Status	Not yet recruiting
Phase	N/A
Start date	March 1, 2018
Completion date	December 31, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04497805` - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers	Phase 2
Withdrawn	`NCT03675269` - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:	N/A
Completed	`NCT04624516` - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence	N/A
Not yet recruiting	`NCT06439667` - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting	`NCT05608187` - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers	Phase 2
Not yet recruiting	`NCT06278935` - Lifestyle Tailored Offloading for Diabetic Foot Ulcers	N/A
Not yet recruiting	`NCT06437028` - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.	N/A
Withdrawn	`NCT05024656` - AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers	N/A
Terminated	`NCT02202668` - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers	N/A
Completed	`NCT01951768` - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection	Phase 4
Terminated	`NCT01966380` - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia	Phase 2
Completed	`NCT01657474` - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers	N/A
Active, not recruiting	`NCT00389636` - TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers	N/A
Completed	`NCT01181440` - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers	Phase 3
Enrolling by invitation	`NCT05888259` - Plantar Pressure Distribution in Diabetic Foot Ulcer	N/A
Completed	`NCT04054804` - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting	`NCT05877378` - Efficacy of PICO Single-use System in Chronic Ulcers	N/A
Recruiting	`NCT06037369` - The Short Message-based Customized Standardized	N/A
Completed	`NCT03312595` - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)	N/A
Recruiting	`NCT04564443` - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot	N/A