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Flexor Tenotomy and Ulcer Recurrence

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ClinicalTrials.gov Identifier: NCT05228340
Recruitment Status : Recruiting
First Posted : February 8, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Marieke Mens, 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.

Condition or disease Intervention/treatment Phase
Hammer Toe Syndrome Foot Ulcer, Diabetic Procedure: Flexor tenotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
Actual Study Start Date : March 15, 2022
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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



Primary Outcome Measures :
  1. Ulcer recurrence [ Time Frame: 24 months ]
    Ulcer recurrence on the toe, adjacent toe, and metatarsal heads


Secondary Outcome Measures :
  1. DIPJ, PIPJ and MTPJ angles [ Time Frame: Baseline, 6 and 12 months ]
    DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing

  2. Barefoot pressure pattern [ Time Frame: Baseline, 6 and 12 months ]
    Barefoot pressure pattern

  3. Patient-reported outcome measures: EuroQol's EQ-5D-5L [ Time Frame: Baseline, 6, 12 and 24 months ]
    Quality of life determined by EQ-5D-5L

  4. Patient-reported outcome measures: SF-36 [ Time Frame: Baseline, 6, 12 and 24 months ]
    Quality of life determined by SF-36

  5. Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years [ Time Frame: 24 months ]
    Cost-effectiveness of additional flexor tenotomy compared to usual-care only



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05228340


Locations
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Netherlands
Amsterdam UMC - location MAMC Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105AZ
Contact: Mens    + 31 020 56 66495    marieke.mens@amsterdamumc.nl   
Principal Investigator: Gino M.M.J. Kerkhoffs, Professor         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Gino M.M.J. Kerkhoffs, MD, PhD Amsterdam University Medical Centers
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Responsible Party: Marieke Mens, Coördinating investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT05228340    
Other Study ID Numbers: NL78504.018.21
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Complications
Diabetes Mellitus
Hammer Toe Syndrome
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
Diabetic Neuropathies
Foot Deformities
Musculoskeletal Diseases