Preventing toe ulcers in diabetic patients through flexor tenotomy
The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
This study is testing whether a procedure called flexor tenotomy can help prevent toe ulcers from coming back in diabetic patients who have had them before.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT05228340 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of flexor tenotomy in preventing the recurrence of toe ulcers in diabetic patients with a history of toe ulceration. It aims to assess changes in interphalangeal and metatarsophalangeal joint angles, barefoot plantar pressure during walking, and quality of life before and after the intervention. The study is a mono-center, investigator-blinded, randomized controlled trial comparing flexor tenotomy to usual care, which includes orthoses and shoe offloading. Outcomes will be measured and compared between the intervention and control groups to determine the efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with diabetes mellitus and a history of claw/hammer toe deformity and toe ulcers.
Not a fit: Patients with open ulcers on their toes or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of toe ulcers in diabetic patients, potentially preventing amputations.
How similar studies have performed: While the specific approach of flexor tenotomy for ulcer prevention is being evaluated, similar interventions have shown promise in managing foot complications in diabetic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC - location MAMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Gino M.M.J. Kerkhoffs, MD, PhD — Amsterdam UMC, location VUmc
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.