Flexor Tenotomy and Ulcer Recurrence

Not Applicable

Recruiting

• Conditions: Hammer Toe Syndrome; Foot Ulcer, Diabetic
• Interventions: Procedure: Flexor tenotomy

• Registration Number: NCT05228340
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The main purpose of this study is to assess the efficacy of flexor tenotomy on the prevention of recurrence of toe ulcers in people with diabetes and a history of toe ulceration. Additionally, the investigators aim to assess interphalangeal joints (IPJ) and metatarsophalangeal joint (MTPJ) angles in a weight-bearing and non-weight-bearing position, bare-foot plantar pressure during walking and quality of life before and after the intervention and compare between study groups.

Detailed Description

Foot ulcers are a frequent problem in patients with diabetes mellitus and can lead to amputations. Prevention of these ulcers is therefore of paramount importance. Claw/hammer toe deformity is commonly seen in patients with diabetes. These deformities increase the risk of ulcer development specifically at the (apex of) the toe. Tenotomy of the tendon of the flexor muscles of the toes (tendon tenotomy) can be used to treat the consequences of claw/hammer toe deformity with the goal to prevent ulcer recurrence. For indication and assessment of outcomes of flexor tenotomy, weight-bearing CT and dynamic barefoot plantar pressure measurement can be used. This mono-center investigator blinded randomized controlled trial will compare the flexor tenotomy with usual care (including orthoses and shoe offloading). The effect on ulcer recurrence, toe joint angles, barefoot plantar pressure and quality of life will be assessed and compared between the intervention and control group.

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Status Verified: 2022-03
• Study Start: 2022-03-15
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-29
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• A minimum age of 18 years
• Sufficient understanding of Dutch/English language
• Capable of filling out informed consent
• Peripheral polyneuropathy
• Diabetes mellitus type 1 or 2
• A minimum of one claw/hammer toe
• A documented history of diabetic ulcers underneath the toe apex in the past 5 years

Exclusion Criteria

• No written informed consent
• Not meeting the inclusion criteria
• Open ulcers on the toes
• Previous participation in the study
• Pregnant women
• Concomitant participation in a study in which the patient is exposed to X-rays

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Flexor tenotomy	Flexor tenotomy

Primary Outcome Measures

Name	Time	Method
Ulcer recurrence	24 months	Ulcer recurrence on the toe, adjacent toe, and metatarsal heads

Secondary Outcome Measures

Name	Time	Method
Barefoot pressure pattern	Baseline, 6 and 12 months	Barefoot pressure pattern
DIPJ, PIPJ and MTPJ angles	Baseline, 6 and 12 months	DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing
Patient-reported outcome measures: EuroQol's EQ-5D-5L	Baseline, 6, 12 and 24 months	Quality of life determined by EQ-5D-5L
Patient-reported outcome measures: SF-36	Baseline, 6, 12 and 24 months	Quality of life determined by SF-36
Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years	24 months	Cost-effectiveness of additional flexor tenotomy compared to usual-care only

Trial Locations

Locations (1)

Amsterdam UMC - location MAMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands