Hammer Toe SyndromeNCT05228340
Flexor Tenotomy and Ulcer Recurrence
A study testing Flexor tenotomy in people with Hammer Toe Syndrome and Foot Ulcer, Diabetic, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hammer Toe Syndrome, Foot Ulcer, Diabetic
- What is being tested?
- Flexor tenotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Mar 2022to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC - location MAMC
Amsterdam, North Holland, 1105AZ
Mens, + 31 020 56 66495, marieke.mens@amsterdamumc.nl
Gino M.M.J. Kerkhoffs, Professor
About this study
Official title: The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Hammer Toe Syndrome, Foot Ulcer, Diabetic
- Being tested
- Flexor tenotomy
- Medical subject headings
- Hammer Toe Syndrome, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexor tenotomyProcedure or surgery
Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Flexor tenotomy Receives: Procedure: Flexor tenotomy |
| Controle | No intervention | Usual-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer recurrence
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
Measured: 24 months
Secondary outcomes (5)
DIPJ, PIPJ and MTPJ angles
DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing
Measured: Baseline, 6 and 12 months
Barefoot pressure pattern
Barefoot pressure pattern
Measured: Baseline, 6 and 12 months
Patient-reported outcome measures: EuroQol's EQ-5D-5L
Quality of life determined by EQ-5D-5L
Measured: Baseline, 6, 12 and 24 months
Patient-reported outcome measures: SF-36
Quality of life determined by SF-36
Measured: Baseline, 6, 12 and 24 months
Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years
Cost-effectiveness of additional flexor tenotomy compared to usual-care only
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start15 Mar 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hammer Toe SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marieke Mens, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Gino M.M.J. Kerkhoffs, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228340
- Sponsor's protocol ID
- NL78504.018.21
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mens MA, Busch-Westbroek TE, Bus SA, van Netten JJ, Wellenberg RHH, Streekstra GJ, Maas M, Nieuwdorp M, Kerkhoffs GMMJ, Stufkens SAS. The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2023 Mar 11;33:101107. doi: 10.1016/j.conctc.2023.101107. eCollection 2023 Jun.
PubMed 36950303
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Flexor Tenotomy on the Prevention of Recurrent Diabetic Foot Ulcers: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05228340
- Acronym / sponsor ID
- NL78504.018.21
- Conditions
- Hammer Toe Syndrome, Foot Ulcer, Diabetic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Flexor tenotomyFlexor tenotomy |
| Controle | No intervention | –Usual-care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- No written informed consent
- Not meeting the inclusion criteria
- Open ulcers on the toes
- Previous participation in the study
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexor tenotomyMinimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon | Procedure or surgery | Intervention |
Primary outcome
Ulcer recurrence
Time frame: 24 months
Ulcer recurrence on the toe, adjacent toe, and metatarsal heads
5 secondary outcomes
DIPJ, PIPJ and MTPJ angles
Time frame: Baseline, 6 and 12 months
Barefoot pressure pattern
Time frame: Baseline, 6 and 12 months
Patient-reported outcome measures: EuroQol's EQ-5D-5L
Time frame: Baseline, 6, 12 and 24 months
Patient-reported outcome measures: SF-36
Time frame: Baseline, 6, 12 and 24 months
Incremental cost-effectiveness in QALY's of flexor tenotomy after 2 years
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 36950303Mens MA, Busch-Westbroek TE, Bus SA, van Netten JJ, Wellenberg RHH, Streekstra GJ, Maas M, Nieuwdorp M, Kerkhoffs GMMJ, Stufkens SAS. The efficacy of flexor tenotomy to prevent recurrent diabetic foot ulcers (DIAFLEX trial): Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2023 Mar 11;33:101107. doi: 10.1016/j.conctc.2023.101107. eCollection 2023 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gino M.M.J. Kerkhoffs, MD, PhD principal investigator
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexor tenotomy in people with Hammer Toe Syndrome and Foot Ulcer, Diabetic, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer recurrence (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05228340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.