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Flexor Tenotomy and Ulcer Recurrence

Primary Purpose

Hammer Toe Syndrome, Foot Ulcer, Diabetic

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Flexor tenotomy
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hammer Toe Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amsterdam UMC - location MAMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Controle

Arm Description

Flexor tenotomy

Usual-care

Outcomes

Primary Outcome Measures

Ulcer recurrence
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads

Secondary Outcome Measures

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

Full Information

First Posted
January 11, 2022
Last Updated
March 15, 2022
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05228340
Brief Title
Flexor Tenotomy and Ulcer Recurrence
Official Title
The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hammer Toe Syndrome, Foot Ulcer, Diabetic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Flexor tenotomy
Arm Title
Controle
Arm Type
No Intervention
Arm Description
Usual-care
Intervention Type
Procedure
Intervention Name(s)
Flexor tenotomy
Intervention Description
Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
Primary Outcome Measure Information:
Title
Ulcer recurrence
Description
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
Time Frame
24 months
Secondary Outcome Measure Information:
Title
DIPJ, PIPJ and MTPJ angles
Description
DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing
Time Frame
Baseline, 6 and 12 months
Title
Barefoot pressure pattern
Description
Barefoot pressure pattern
Time Frame
Baseline, 6 and 12 months
Title
Patient-reported outcome measures: EuroQol's EQ-5D-5L
Description
Quality of life determined by EQ-5D-5L
Time Frame
Baseline, 6, 12 and 24 months
Title
Patient-reported outcome measures: SF-36
Description
Quality of life determined by SF-36
Time Frame
Baseline, 6, 12 and 24 months
Title
Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years
Description
Cost-effectiveness of additional flexor tenotomy compared to usual-care only
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gino M.M.J. Kerkhoffs, MD, PhD
Organizational Affiliation
Amsterdam University Medical Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC - location MAMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mens
Phone
+ 31 020 56 66495
Email
marieke.mens@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Gino M.M.J. Kerkhoffs, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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Flexor Tenotomy and Ulcer Recurrence

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