Treatment of Impending Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting

NCT04154046 | Completed DMC

• 1 other identifier: TODDIII
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

Patients with diabetes, hammer, mallet and claw toes and impending ulcers associated with hammer mallet and claw toes will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. Impending ulcers are defined as callus or nail changes that are known pre-stages to ulcers. The effects of the surgery on incidence of ulcers associated with the named deformities, and rate of complications associated with the surgery.

Conditions

Diabetic Foot; Hammer Toe; Mallet Toe; Claw Toe

Outcome Measures

Primary Outcomes (1)

• New ulcers incurred

  Number of new ulcers incurred, defined as ulcers associated with hammer, mallet and claw toe deformities, placed on treated foot

  1 year

Secondary Outcomes (5)

• Incidence of minor amputations

  1 year

• Incidence of major amputations

  1 year

• incidence of secondary infection

  1 year

• Transfer lesion incidence

  1 year

• Incidence of new ulcers on feet

  1 year

Study Arms (2)

Tenotomy

EXPERIMENTAL

Patients allocated to this arm receive tenotomy treatment of affected toes, and standard care including offloading treatment

Procedure: Tenotomy(cutting) of flexor tendons is performed with needle

standard care

NO INTERVENTION

Patient who are randomized to this arm receive standard care including offloading treatment

Interventions

Tenotomy(cutting) of flexor tendons is performed with needle PROCEDURE

Patient is placed in seated posture with feet elevated. The toe(s) with hammer, mallet or claw toe deformity is anesthetized by a digital toe block with 1-5 ml of 1% lidocaine administered for each toe. The toe digital block is administered through a plantar approach, at the web level of the deformed toe(s), with a 0,6 mm diameter and 30mm long needle. After anesthetizing the toe(s) the plantar aspect of the toe at web level is disinfected with an alcohol based disinfectant twice. Both the long and short flexors are then severed with a 1.2mm diameter and 40mm long needle through a plantar approach, immediately proximal to the web level of the toe. After the procedure a dry gauze bandage is applied and the patients treated foot/feet is/are elevated for 20 minutes to achieve haemostasis, and the bandage is checked for bleeding before discharge.

Tenotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or above
• Type 1 or 2 diabetes
• Hammer, mallet or claw toe deformity
• Impending ulcer associated with above mentioned deformities
• Able to understand written and oral information
• Ability to follow planned visits and treatment
• Able to provide informed consent in Danish and/or English

You may not qualify if:

• Revascularization procedure in the affected limb planned, or undertaken within the 4 weeks prior to screening
• Hammer, mallet and claw toe that are rigid in both MTP and IP joints
• Ulcer associated with hammer, mallet and claw toe deformities
• Toe pressure \< 30mmHg
• Prior major amputations on affected or ipsilateral leg
• Other corrective operation is indicated to treat patients foot deformities as deemed by investigator
• Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
• Treatment of foot ulcers with growth factors, stem cells or equivalent preparations within the 8 weeks prior to screening
• Likely inability to comply with the need for planned visits because of planned activity
• Participation in another interventional clinical foot ulcer-healing trial within the 4 weeks prior to screening
• Prior enrolment in this trial
• Judgement by the investigator that the patient does not have the capacity to understand the study procedures or provide written informed consent

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Bispebjerg Hospital: collaborator
• Hillerod Hospital, Denmark: collaborator

Study Sites (3)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Hospitalerne i Nordsjælland Hillerød Hospital Ortopædkirurgisk afdeling

Hillerød, 3400, Denmark

Location

Videncenter for Sårheling Bispebjerg Hospital

København NV, 2400, Denmark

Location

MeSH Terms

Conditions

Diabetic Foot; Hammer Toe Syndrome

Interventions

Needles

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients WHO meet all inclusion and non of the exclusion criteria are randomly allocated to two arms in the study. The allocation is stratified by treatment center.

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: November 6, 2019
• Study Start: November 1, 2019
• Primary Completion: August 3, 2021
• Study Completion: October 28, 2021
• Last Updated: November 1, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Protocol, SAP and ICF shared here

Locations

DK (3)