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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154046
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Bispebjerg Hospital
Hillerod Hospital, Denmark
Information provided by (Responsible Party):
Steno Diabetes Center Copenhagen

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Hammer Toe Mallet Toe Claw Toe Procedure: Tenotomy(cutting) of flexor tendons is performed with needle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Treatment of Impending Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Tenotomy
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

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.


No Intervention: standard care
Patient who are randomized to this arm receive standard care including offloading treatment



Primary Outcome Measures :
  1. New ulcers incurred [ Time Frame: 1 year ]
    Number of new ulcers incurred, defined as ulcers associated with hammer, mallet and claw toe deformities, placed on treated foot


Secondary Outcome Measures :
  1. Incidence of minor amputations [ Time Frame: 1 year ]
    Incidence of minor amputations

  2. Incidence of major amputations [ Time Frame: 1 year ]
    Incidence of major amputations

  3. incidence of secondary infection [ Time Frame: 1 year ]
    incidence of secondary infection as deemed by treating physician

  4. Transfer lesion incidence [ Time Frame: 1 year ]
    Transfer lesions defined as impending ulcers or actual ulcers at anatomical sites associated with hammer, mallet and claw toes in patients with diabetes, on non-treated hammer, mallet and claw toes after surgical treatment)

  5. Incidence of new ulcers on feet [ Time Frame: 1 year ]
    Measured in incidence of new ulcers, defined as ulcer in different anatomical position than the treated ulcer(s) and associated with hammer, mallet or claw toes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154046


Contacts
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Contact: Jonas Hedegaard Andersen, Md +4523258084 jonas.hedegaard.andersen@regionh.dk

Locations
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Denmark
Steno Diabetes Center Copenhagen Recruiting
Gentofte, Denmark, 2820
Contact: Jonas Hedegaard Andersen, Md    +4523258084    jonas.hedegaard.andersen@regionh.dk   
Hospitalerne i Nordsjælland Hillerød Hospital Ortopædkirurgisk afdeling Recruiting
Hillerød, Denmark, 3400
Contact: Jonas Hedegaard Andersen, Md    +4523258084    jonas.hedegaard.andersen@regionh.dk   
Videncenter for Sårheling Bispebjerg Hospital Recruiting
København NV, Denmark, 2400
Contact: Jonas Hedegaard Andersen, Md    +4523258084    jonas.hedegaard.andersen@regionh.dk   
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Bispebjerg Hospital
Hillerod Hospital, Denmark
  Study Documents (Full-Text)

Documents provided by Steno Diabetes Center Copenhagen:
Informed Consent Form  [PDF] October 8, 2019

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Responsible Party: Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04154046    
Other Study ID Numbers: TODDIII
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Protocol, ICF, and SAP will be shared when possible
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Protocol, SAP and ICF shared here

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hammer Toe Syndrome
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Deformities
Musculoskeletal Diseases