Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT04154020
Recruitment Status : Recruiting
First Posted : November 6, 2019
Last Update Posted : November 6, 2019
Sponsor:
Collaborators:
University Hospital Bispebjerg and Frederiksberg
Hillerod Hospital, Denmark
Information provided by (Responsible Party):
Jonas Hedegaard Andersen, Steno Diabetes Center Copenhagen

Brief Summary:
  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. 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.

Patients will attend a total of up to 14 visits over a 12-month period.

3.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Hammer Toe Mallet Toe Claw Toe Procedure: Flexor tenotomy Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting
Estimated Study Start Date : November 30, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2022

Arm Intervention/treatment
Experimental: Tenotomy
Patients allocated to this arm receive tenotomy treatment of affected toes, and standard care including offloading treatment
Procedure: Flexor tenotomy
Tenotomy(cutting) of flexor tendons is performed with needle

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



Primary Outcome Measures :
  1. Mean time to healing of ulcers(s) in treated limb [ Time Frame: Measured at visits (1,3, 5, 7, 9, 10 weeks and 3, 6 and 12 months) ]
    Measured in days


Secondary Outcome Measures :
  1. Mean time to healing of incision sites [ Time Frame: Measured at visits (1,3, 5, 7, 9, 10 weeks and 3, 6 and 12 months) ]
    Measured in days

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

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

  4. Plantar pressure profile [ Time Frame: 3 months ]
    Measured in mmhg from the gait analysis

  5. trembling [ Time Frame: 3 months ]
    mean COP velocity

  6. Rambling [ Time Frame: 3 months ]
    measured in COP range and sway path length

  7. incidence of secondary infection [ Time Frame: 1 year ]
    Incidence of infection during observation period, as demmed by investigator

  8. Pain in treated limb, associated with tenotomy [ Time Frame: 1 year ]
    Patient reported pain associated with treatment

  9. 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),

  10. Recurrence of ulcers on the treated limb [ Time Frame: 1 year ]
    Measured in incidence of recurrent ulcers, defined as ulcer in same anatomical position as treated ulcer after complete healing

  11. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

Exclusion Criteria

  • 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

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): NCT04154020


Contacts
Layout table for location contacts
Contact: Jonas Hedegaard Andersen, Md +4523258084 jonas.hedegaard.andersen@regionh.dk

Locations
Layout table for location information
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
University Hospital Bispebjerg and Frederiksberg
Hillerod Hospital, Denmark
Investigators
Layout table for investigator information
Study Director: Peter Rossing, Prof MD Steno Diabetes Cneter Copenhagen
  Study Documents (Full-Text)

Documents provided by Jonas Hedegaard Andersen, Steno Diabetes Center Copenhagen:
Informed Consent Form  [PDF] October 1, 2019


Layout table for additonal information
Responsible Party: Jonas Hedegaard Andersen, Orthopedic Consultant & Clinical Assistant, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT04154020     History of Changes
Other Study ID Numbers: TODD II
First Posted: November 6, 2019    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonas Hedegaard Andersen, Steno Diabetes Center Copenhagen:
tenotomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hammer Toe Syndrome
Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Foot Deformities
Musculoskeletal Diseases