Skip to content

Percutaneous flexor tenotomy with toe deformity in diabetic patients.

Percutaneous flexor tenotomy with toe deformity in diabetic patients. - Percutaneous flexor tenotomy.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39421
Enrollment
60
Registered
2013-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hamertoe. Diabetic foot wound

Interventions

Under local anesthesia, the flexor digitorum longus of the corresponding toe is percutaneously cleaved using a small knife of about 2mm in width (Admix non-coring needle). The wound that is made on

Sponsors

Atrium Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients older than 18 years of age (female and male) - Patients with hamertoe and existing wounds on the concerning toe. - Wound exists longer than 3 months and is treated at the diabetic foot clinic - Patients with diabetes mellitus and treated by the general practitioner or by the Internal medicine physician - Osteomyelitis (patients with osteomyelitis on the toe due to a non-healing wound caused by a hammer toe, are also included). Osteomyelitis is diagnosed using radiographic photography ( an obvious cortical disruption can be seen here). This x-ray is requested by the diabetic foot clinic and belongs to the standard care (covered by regular health insurance).

Exclusion criteria

Exclusion criteria: - Halluxpressure lower than 40mmHg, measured at the vascular laboratory in accordance with regular care - Last new orthopedic footwear less than 26weeks old - Antibiotic use 2 weeks prior to operation - Antibiotic use for other indications than use for the affected foot, and 3 weeks after surgery - Note: Amputation of another toe in the past is no reason for exclusion

Design outcomes

Primary

MeasureTime frame
Primary outcome measure: - Cure rate of the existing wound on the treated toe. This is defined as the number of healed wounds on the treated toe, if complete epithelialization occurred, after a year and is measured in the absolute number that is healed. The cure is determined by the classification pedis. The pedis scale consists of 5 items with the following corresponding classification: * Perfusion: 1) absence of PAD, 2) symptoms of PAD, however, no critical    ischemia, 3) existence of critical ischaemia. * Scope: The size of the ulcer measured in mm x mm after wonddebridement has taken place. * Depth: 1) surface, 2) the ulcer penetrates to the subcutaneous structures    such as fascia, muscle or tendon, 3) all underlying layers are involved including bone and / or    joint. * Infection: 1) absence of infection, 2) the case of infection of the skin, and    the subcutaneous tissue, 3) erythema greater than 2 cm or deeper than the    skin or subcutis but without systemic inflammatory symptoms, 4) clear    systemic symptoms of infection. * Sensation: 1) no loss of protective sensation, 2) loss of    protective sensation - Healing Trend existing wound: This is defined as the degree of healing, reduction of scale / size wound. Is determined by the classification pedis. - Healing Time existing wound to the treated toe. This is defined by the Nurse practitioner as the time from the interventiondate until the day the wound is cured , measured in number of days. This is also determined by the classification pedis.

Secondary

MeasureTime frame
Secondary outcome measure: - New wound to the treated toe. This is defined as a wound other than the existing wound at the time of the intervention, as it may be in the same place as in any other place but in the same toe. Is determined by the classification Pedis. - Caused infection of the treated toe This is defined as: There must be at least one of the following clinical symptoms: redness, local swelling or heat to the treated toe. This is measured in temperature (fever), skin temperature, blood values **Leukocytes + C-reactive protein (CRP) and also through the Pedis classification. Fever: At temperature> 38.50 C (ear thermometer). Skin temperature: Infection> 20C difference with the other foot (skin thermometer). Leukocytes> 10 E9 / L infection. CRP> 10mg / L infection. - Wound size of the existing wound. This is defined as the extent of the wound and is measured in millimeters x millimeters, with a wound centimeter measurer, and is also classified by the pedis classification . - Wound Classification This is defined on the causes and characteristics of a diabetic foot ulcer and is measured according to the classification pedis - Complication lingering toe (grasping toe)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)