Flexor Tenotomy and Ulcer Recurrence

The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hammer Toe Syndrome; Foot Ulcer, Diabetic
• Intervention / Treatment: Procedure: Flexor tenotomy

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC - location MAMC
      • Contact: Mens; Phone Number: + 31 020 56 66495; Email: marieke.mens@amsterdamumc.nl
      • Principal Investigator: Gino M.M.J. Kerkhoffs, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Flexor tenotomy	Procedure: Flexor tenotomy; Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
No Intervention: Controle; Usual-care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ulcer recurrence	Ulcer recurrence on the toe, adjacent toe, and metatarsal heads	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Gino M.M.J. Kerkhoffs, MD, PhD, Amsterdam University Medical Centers

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): February 1, 2027
• Study Completion (Anticipated): February 1, 2027

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Musculoskeletal Diseases; Foot Deformities; Diabetic Foot; Foot Ulcer; Ulcer; Hammer Toe Syndrome
• Other Study ID Numbers: NL78504.018.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No