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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC - location MAMC
RECRUITING
Amsterdam
Time Frame
Start Date: 2022-03-15
Estimated Completion Date: 2027-02
Participants
Target number of participants: 66
Treatments
Experimental: Intervention
Flexor tenotomy
No_intervention: Controle
Usual-care
Related Therapeutic Areas
Sponsors
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

This content was sourced from clinicaltrials.gov