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Passive Training as a Treatment for Diabetic Foot Ulcers

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ClinicalTrials.gov Identifier: NCT02785198
Recruitment Status : Unknown
Verified June 2016 by Tue Smith Jørgensen, Herlev Hospital.
Recruitment status was:  Recruiting
First Posted : May 27, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Tue Smith Jørgensen, Herlev Hospital

Brief Summary:

Overall project design: This PhD project involves a randomized study on diabetic individuals with healing resistant wounds, comparing the effect of passive movement of the lower limb with standard treatment of diabetic wounds.

How to effectively improve the condition of peripheral arterial disease is limited. The primary purpose of this study is to uncover whether passive movement of the lower limb will influence muscle oxygen demand and thereby increasing blood flow. An increase in muscle oxygen demand is likely to increase both blood flow rate and the number of capillaries, which would induce the healing of wounds, that were not previously possible.

The secondary purpose is to increase understanding of the pathophysiological processes in wound healing through the study of biochemical markers of vascularization, inflammation and stem cell recruitment in blood samples. Further on analyzing the skin and muscle biopsies of the number and quality of endothelial cells and Capillary density and to develop new quantifiable methods to evaluate wound healing in.

The project is a randomized trial, consisting of simple passive training to improve blood vessel function, increase the growth of the smallest blood vessels, thereby preventing ulceration and ultimately amputation.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcers Device: Passive knee extensor machine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Passive Training as a Treatment for Diabetic Foot Ulcers: A Randomized, Single-blinded Clinical Trial of Wound Healing
Study Start Date : April 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
A control group receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics.
Experimental: Passive training group
An Intervention group doing passive exercise for 8 weeks and receiving standard wound treatment consisting of debridement, dressings, compression, offloading footwear and if necessary antibiotics.
Device: Passive knee extensor machine
The passive training machine, moves both legs from flexion to extension and back, 60 times per minute in 1 hour, 3 times per week. ROM is 60 degrees




Primary Outcome Measures :
  1. Wound healing change quantified by digital photo planimetry [ Time Frame: Photos are taken at week 0 and 8 ]
    The digital photo planimetry measurements are compared to the baseline measurement at week 0

  2. The change in Wagner's wound classification. [ Time Frame: week 0 and 8 ]
    measurements at baseline are compared to week 8

  3. The change in Wagner's wound classification. [ Time Frame: week 3, 5 and 16 ]
    The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8

  4. Wound healing change quantified by digital photo planimetry [ Time Frame: week 3, 5 and 16 ]
    The measurements at week 3, 5 and 16 are compared to the baseline week 0 and 8


Secondary Outcome Measures :
  1. Perfusion of the lower extremity. [ Time Frame: week 0, 3, 5, 8 and 16. ]
    Quantified by measuring the blood flow in arteria femoralis (doppler)

  2. Distal blood pressure measurement. [ Time Frame: week 0 and 8. ]
    Includes skin perfusion test

  3. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Hemoglobin mmol/L

  4. Histological changes of the muscle tissue. [ Time Frame: Week 0,5 and 8 ]
    Analysed from muscle biopsies

  5. Histological changes of the tissue composition in the edge of the wound. [ Time Frame: Week 0,5 and 8 ]
    Analysed from wound edge biopsy

  6. Angiogenetic factors analysed from muscle biopsy [ Time Frame: Week 0,5 and 8 ]
    • Total RNA isolated from the muscle biopsies, and the mRNA content of VEGF, eNOS, MMP-2, MMP-9, TIMP-1, TIMP-2, Tie-2, ANG-1, ANG-2 determined by PCR

  7. Dexa Scanning of the lower limb. [ Time Frame: Week 0 and 8 ]
    To measure the tissue composition change

  8. Dexa Scanning of the lower limb. [ Time Frame: Week 0 and 8 ]
    To measure the bone mineral density change

  9. Patient related outcome measurements (PROM's) [ Time Frame: Week 0, 8 and 16 ]
    Medical Outcome Study Short Form 36 (MOS SF36)

  10. the change in 30 second chair stand test [ Time Frame: Week 0 and 8 ]
  11. the change in maximum leg extension test [ Time Frame: Week 0 and 8 ]
  12. Adverse events [ Time Frame: Week 0, 3, 5, 8 and 16 ]
  13. Autonomic neuropathy [ Time Frame: Week 0 and 8 ]
    vagus device measurements at baseline and after 8 weeks

  14. Distal blood pressure change measurement. [ Time Frame: week 0 and 8 ]
    Arm, ankle and toe pressure. The ankle brachial index (ABI) is calculated from measuring the arm and ankle systolic blood pressure.

  15. Autonomic neuropathy [ Time Frame: Week 0 and 8 ]
    sudoscan measurements at baseline and after 8 weeks

  16. Patient related outcome measurements (PROM's) [ Time Frame: Week 0, 8 and 16 ]
    the Euroqol five Dimensions questionnaire (EQ-5D)

  17. Histological changes of the endothelial cells [ Time Frame: 0,5 and 8 ]
    analysed from muscle biopsies

  18. Histological changes of the capillary density [ Time Frame: 0,5 and 8 ]
    Analysed from muscle biopsies

  19. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Glycated HbA1c in mmol/mol

  20. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Glucose in mmol/l

  21. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    C-reactive protein in mg/L

  22. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    leucocytes and differential count, in 10^9/L

  23. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Thrombocytes in 10^9/L

  24. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Sodium,mmol/L

  25. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    potassium in mmol/L

  26. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    eGlomerular filtration rate, mL/min/1,73 m^2

  27. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Albumin g/L

  28. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Creatinine, μmol/L

  29. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Alanine Transaminase, U/L

  30. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    Basic Phosphatase, U/L

  31. The biochemical changes during wound healing, is assessed by biochemical markers in peripheral venous blood samples. [ Time Frame: Week 0, 5 and 8 ]
    YKL 40, μg/L



Information from the National Library of Medicine

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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:

  1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  2. Diabetes mellitus according to the World Health Organisation (WHO) criteria (see http://www.who.int/diabetes/publications/en/ ) and a stable treatment treated in a period of 14 days prior to screening with insulin or an oral antidiabetic agent. Stable is defined as stable HBA1c.

4. Foot ulcer: size: diameter > 1cm. Duration of wound > 6 weeks Location: Full thickness skin defect distal to the malleoli.

5. Male or female, age >18 years at the time of signing informed consent. 6. Non-dementia diagnosis.

Exclusion Criteria:

  1. Major infection; acute cellulitis, osteomyelitis or gangrene anywhere in the affected extremity.
  2. Malignant disease
  3. Major traumatic tissue damage.
  4. Major lower extremity amputation.

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): NCT02785198


Contacts
Contact: Tue Smith Joergensen, MD 004538681473 tue.smith.joergensen.01@regionh.dk
Contact: Hans Gottlieb, MD. PhD 004538681171 hans.gottlieb.03@regionh.dk

Locations
Denmark
Herlev Hospital Recruiting
Herlev, Capital region of Denmark, Denmark, 2730
Contact: Tue Smith Joergensen, MD    0045 38681473    tuesmith@gmail.com   
Sponsors and Collaborators
Herlev Hospital
University of Copenhagen
Investigators
Principal Investigator: Tue Smith Joergensen, MD Herlev and Gentofte Hospital, The Department of Orthopedics

Publications:

Responsible Party: Tue Smith Jørgensen, Medical Doctor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT02785198     History of Changes
Other Study ID Numbers: H-15008102
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot 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