Flexor Tenotomy and Ulcer Recurrence

Foot Ulcer, Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228340
• Other study ID #: NL78504.018.21
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: February 2027

Study information

• Verified date: March 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: February 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

Intervention

Procedure:
• Flexor tenotomy
Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC - location MAMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcer recurrence	Ulcer recurrence on the toe, adjacent toe, and metatarsal heads	24 months
Secondary	DIPJ, PIPJ and MTPJ angles	DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing	Baseline, 6 and 12 months
Secondary	Barefoot pressure pattern	Barefoot pressure pattern	Baseline, 6 and 12 months
Secondary	Patient-reported outcome measures: EuroQol's EQ-5D-5L	Quality of life determined by EQ-5D-5L	Baseline, 6, 12 and 24 months
Secondary	Patient-reported outcome measures: SF-36	Quality of life determined by SF-36	Baseline, 6, 12 and 24 months
Secondary	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