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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Flexor tenotomy |
|
| Controle | No Intervention | Usual-care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flexor tenotomy | Procedure | Minimally-invasive percutaneous needle flexor tenotomy of the long digital flexor tendon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer recurrence | Ulcer recurrence on the toe, adjacent toe, and metatarsal heads | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| DIPJ, PIPJ and MTPJ angles | DIPJ, PIPJ and MTPJ angles during weight-bearing and non-weight-bearing | Baseline, 6 and 12 months |
| Barefoot pressure pattern | Barefoot pressure pattern |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gino M.M.J. Kerkhoffs, MD, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC - location MAMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36950303 | Derived | 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. |
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| ID | Term |
|---|---|
| D037801 | Hammer Toe Syndrome |
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Baseline, 6 and 12 months |
| Patient-reported outcome measures: EuroQol's EQ-5D-5L | Quality of life determined by EQ-5D-5L | Baseline, 6, 12 and 24 months |
| Patient-reported outcome measures: SF-36 | Quality of life determined by SF-36 | 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 | 24 months |
| D002318 |
| Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |