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

NCT04154020 | Completed DMC

• 1 other identifier: TODD II
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

1. 1.Aim Patients with diabetes, hammer, mallet and claw toes and ulcers associated with the named deformities will be randomized to tenotomy (cutting) of flexor tendons to the afflicted toes, done by needle and standard offloading or offloading alone. The effects of the surgery on time to healing of ulcers associated with the named deformities, recurrence of the ulcers, and rate of complications associated with the surgery. In addition to this all patients gait and balance will be examined before start of the study, and after 3 months, to se if there is an effect of the surgery on patients gait and balance.
2. 2.Method A prospective randomized clinical study, which means a study were patients will be allocated randomly to surgery and standard care or standard care alone.

Conditions

Diabetic Foot Ulcer; Hammer Toe; Mallet Toe; Claw Toe

Keywords

tenotomy

Outcome Measures

Primary Outcomes (1)

• Mean time to healing of ulcers(s) in treated limb

  Measured in days

  Measured at visits (1,3, 5, 7, 9, 10 weeks and 3, 6 and 12 months)

Secondary Outcomes (11)

• Mean time to healing of incision sites

  Measured at visits (1,3, 5, 7, 9, 10 weeks and 3, 6 and 12 months)

• Incidence of minor amputations

  1 year

• Incidence of major amputations

  1 year

• Plantar pressure profile

  3 months

• trembling

  3 months

Study Arms (2)

Tenotomy

EXPERIMENTAL

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

Procedure: Flexor tenotomy

standard care

NO INTERVENTION

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

Interventions

Flexor tenotomy PROCEDURE

Tenotomy(cutting) of flexor tendons is performed with needle

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 as judged by investigator
• 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, claw and mallet toe that are completely rigid in both MTP and IP joints
• Toe blood pressure lower than 30mmHg
• Infections of the foot ulcer needing surgical treatment
• 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
• University Hospital Bispebjerg and Frederiksberg: 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

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

Study Officials

• Peter Rossing, Prof MD

  Steno Diabetes Cneter Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Consultant & Clinical Assistant

Model Details: Patients who meet all inclusion and no exclusion criteria are randomly allocated to two arms in the study. The allocation is stratified by treatment center.

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: November 6, 2019
• Study Start: November 30, 2019
• Primary Completion: August 3, 2021
• Study Completion: October 28, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

DK (3)