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Vibration Enhances Diabetic ULCER Healing (VIBEDULCER)

Primary Purpose

Diabetic Foot Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Magnitude High Frequence Vibration Platform
Conventional Dressing
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer focused on measuring Vibration, Whole Body Vibration, Low Magnitude High Frequency Vibration, Biophysical Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • >18 years old (legally able to self-sign consent)
  • Able to stand independently
  • Biochemically confirmed Diabetes with a fasting plasma glucose ≥ 7.0 mmol/L, or a random plasma glucose ≥ 11.1 mmol/L or hemoglobin A1c (HbA1c) level ≥ 6.5%
  • Ulcers will be below the level of the malleoli, excluding those confined to the interdigital web space
  • Cross-sectional area of the index ulcer should be 50- 1000 mm2
  • Wagner stage 2-3
  • Not active infection according to the Infectious Diseases Society of America guidelines

Exclusion criteria:

  • Severe cognitive impairment or severe comorbidity, which may impair ability to adhere to intervention plan, e.g. severe dementia, poor cardiopulmonary reserve requiring home oxygen, daily hemodialysis etc.
  • Evidence of active infection
  • Recent revascularization procedure (<12 weeks)
  • Recently received medication/intervention which might affect cell proliferation (eg chemotherapy, radiotherapy etc)
  • Allergy to dressing, adhesives or antibiotics
  • Incapable to understand the study protocol or provide written informed consent

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Control group: conventional dressing

    Vibration group: conventional dressing and LMHFV

    Arm Description

    Alternate day dressing in a designated clinic by a trained nurse specialized in wound care Dressing by a specialized wound-nurse is the current gold-stand of treatment for diabetic ulcers.

    Alternate day dressing in a designated clinic by a trained nurse specialized in wound care Alternate dat 20-week course of whole-body vibration therapy Alternate day 20min sessions on a self-designed vibration platform with low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement <0.1mm). Since the participants will return for dressing change on alternate days, the vibration group will also undergo the LMHFV on the same attendance.

    Outcomes

    Primary Outcome Measures

    Ulcer size
    • The baseline ulcer size will be measured at 0 weeks and a core interim measurement will be conducted at 20 weeks since 30% of ulcerations will heal at 20 weeks using conventional dressing. (13) A 1-year reassessment will help differentiate if the 20-week course of LMHFV therapy has created sustainable changes.

    Secondary Outcome Measures

    Time (days) to healing
    • The day of complete wound closure will be documented during their alternate day dressings in the designated clinic. The participant will still be reviewed at 20 weeks and 1 year for the primary outcome.
    Incidence of amputation
    • The reason and day of below knee/above knee amputation will be recorded. Details will be retrieved from the Clinical Management System, the centralized electronic healthcare system utilized by public hospitals in Hong Kong.
    Incidence of secondary infection
    • The number of hospitalized days and number of days of systemic antibiotic therapy will be documented. Details will be retrieved from the Clinical Management System, the centralized electronic healthcare system utilized by public hospitals in Hong Kong.
    Perfusion
    • The measurement of the ABI will be standardized. (24) The subject will be at rest in supine position for 10mins, Doppler ultrasound to measure systolic blood pressure twice in the posterior tibial artery (If there is no obtainable signal in the posterior tibial artery, the dorsalis pedis will be used.), the average systolic blood pressure in the posterior tibial artery/dorsalis pedis divided by the higher of the SBP in the two arms will be used to calculate the ABI. (The higher SBP of the arm will be used in these calculations due to previous studies showing a strong association between peripheral arterial disease and subclavian stenosis)
    Foot function
    • Foot function will be measured using the FAOS which is a variant of the KOOS specific for problems related to the foot and ankle region. The FAOS also has validated translations in English and Chinese; it is a questionnaire consisting of 5 Likert score subscales; Pain, Symptoms, ADL, Recreation and Foot related QOL. Answers are graded a score from 0-4 and a normalised score can be calculated for each subscale (100 is asymptomatic while 0 indicates extreme symptoms).

    Full Information

    First Posted
    February 13, 2020
    Last Updated
    July 26, 2021
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04275804
    Brief Title
    Vibration Enhances Diabetic ULCER Healing
    Acronym
    VIBEDULCER
    Official Title
    Enhancement of Diabetic Foot Ulcer Healing Using Low-Magnitude High-Frequency Vibration Treatment - A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Objectives: Diabetes has a prevalence of 11.6% in China with diabetic foot ulcerations affecting over 30 million Chinese. 85% of these patients require amputation and 5-year mortality for diabetics is 70% when associated foot ulcers. Clinical trials have shown that standing on whole-body vibration platforms, specifically low-magnitude high-frequency vibration (LMHFV); promotes angiogenesis, enhances muscle bulk and accelerates epithelization. Investigation on diabetic rats with foot wounds found accelerated wound healing, increased perfusion and upregulation of factors such as VEGF, PECAM-1 and PCNA. Hypothesis: The investigators postulate LMHFV will enhance diabetic foot ulcer healing. Design and Subjects: Prospective, single-centre, randomised control trial to treat 106 subjects with diabetic foot ulcers. Interventions: The intervention group will stand on LMHFV whole-body vibration platforms for 20min on alternate days for 20 weeks, together with conventional dressing by a trained wound-care nurse as in the control group. Main Outcome Measures: Ulcer size will be measured at multiple time points, the incidence of amputations/infections will be recorded, perfusion via ankle-brachial pressure index will be calculated and foot function via the foot and ankle outcome score will be analysed. Data analysis: Repeated measure of ANOVA to analyze time-point differences and student's t-test for same time-point comparison. Expected Results: This is the first clinical trial to investigate the effect of whole-body vibration on diabetic foot ulcers. It will show the investigators if the results from animal studies will translate into clinically significant results. If positive effects are established, whole-body vibration can be a valuable treatment regime to tackle diabetic foot ulcers.
    Detailed Description
    Plan of Investigation: (fig 04 in supplementary notes, CONSORT diagram) Subjects: Participants will be recruited from the patients in the Orthopaedic & Traumatology department at the Prince of Wales Hospital, the tertiary teaching hospital affiliated to CUHK. Sample size: 106 subjects randomized 1:1 into the two treatment groups accounting for a dropout rate of 15%. The sample size was calculated by using the primary endpoint of wound size in G*Power 3.1.9.4 (Germany). Using a 1:1 randomization ratio a type I error rate (a-level) of 0.05 and power of 0.95. Our vibration study of diabetic rat wounds showed an effect size d of 0.99. We estimate a tuned-down effect in human subjects, thus using an effect size of 0.7 we calculated that we should recruit 90 participants with 45 in each group. (22) Methods: Study Design: Randomized Controlled Trial 1:1 randomization into control n=58 or intervention (Vibration) group n=58. Intervention Control group: conventional dressing Vibration group: conventional dressing + LMHFV Data Analysis: Randomisation performed using computer-generated randomization with a 1:1 allocation ratio using permuted block randomization to ensure similar numbers in the control and vibration group. Compliance to intervention: Conventional dressing: Each attendance to wound dressing will be recorded by the clinic nurse; those with <60% attendance to the wound clinic will be excluded. LMHFV Vibration: each participant in the vibration intervention group will be assigned a personal 'smart card'. This smart card will record each utilization of the vibration platform to ensure compliance, those with <66% attendance will be excluded. Repeated measures of ANOVA will be used to analyze the ulcer size groups and time points differences with be analyzed with post-hoc Bonferroni tests. Student's t-test for two independent samples will be used to compare groups of the same time point. Statistical analyses will be performed using IBM SPSS 25 (IBM, Armonk, NY, USA), and statistical significance was considered at p < 0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Foot Ulcer
    Keywords
    Vibration, Whole Body Vibration, Low Magnitude High Frequency Vibration, Biophysical Intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group: conventional dressing
    Arm Type
    Active Comparator
    Arm Description
    Alternate day dressing in a designated clinic by a trained nurse specialized in wound care Dressing by a specialized wound-nurse is the current gold-stand of treatment for diabetic ulcers.
    Arm Title
    Vibration group: conventional dressing and LMHFV
    Arm Type
    Experimental
    Arm Description
    Alternate day dressing in a designated clinic by a trained nurse specialized in wound care Alternate dat 20-week course of whole-body vibration therapy Alternate day 20min sessions on a self-designed vibration platform with low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement <0.1mm). Since the participants will return for dressing change on alternate days, the vibration group will also undergo the LMHFV on the same attendance.
    Intervention Type
    Device
    Intervention Name(s)
    Low Magnitude High Frequence Vibration Platform
    Intervention Description
    with low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement <0.1mm)
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Dressing
    Intervention Description
    Alternate Day Dressing
    Primary Outcome Measure Information:
    Title
    Ulcer size
    Description
    • The baseline ulcer size will be measured at 0 weeks and a core interim measurement will be conducted at 20 weeks since 30% of ulcerations will heal at 20 weeks using conventional dressing. (13) A 1-year reassessment will help differentiate if the 20-week course of LMHFV therapy has created sustainable changes.
    Time Frame
    0weeks, 2weeks, 8weeks, 14weeks, 20weeks, 56weeks
    Secondary Outcome Measure Information:
    Title
    Time (days) to healing
    Description
    • The day of complete wound closure will be documented during their alternate day dressings in the designated clinic. The participant will still be reviewed at 20 weeks and 1 year for the primary outcome.
    Time Frame
    up to 56 weeks
    Title
    Incidence of amputation
    Description
    • The reason and day of below knee/above knee amputation will be recorded. Details will be retrieved from the Clinical Management System, the centralized electronic healthcare system utilized by public hospitals in Hong Kong.
    Time Frame
    up to 56 weeks
    Title
    Incidence of secondary infection
    Description
    • The number of hospitalized days and number of days of systemic antibiotic therapy will be documented. Details will be retrieved from the Clinical Management System, the centralized electronic healthcare system utilized by public hospitals in Hong Kong.
    Time Frame
    up to 56 weeks
    Title
    Perfusion
    Description
    • The measurement of the ABI will be standardized. (24) The subject will be at rest in supine position for 10mins, Doppler ultrasound to measure systolic blood pressure twice in the posterior tibial artery (If there is no obtainable signal in the posterior tibial artery, the dorsalis pedis will be used.), the average systolic blood pressure in the posterior tibial artery/dorsalis pedis divided by the higher of the SBP in the two arms will be used to calculate the ABI. (The higher SBP of the arm will be used in these calculations due to previous studies showing a strong association between peripheral arterial disease and subclavian stenosis)
    Time Frame
    0weeks, 20weeks
    Title
    Foot function
    Description
    • Foot function will be measured using the FAOS which is a variant of the KOOS specific for problems related to the foot and ankle region. The FAOS also has validated translations in English and Chinese; it is a questionnaire consisting of 5 Likert score subscales; Pain, Symptoms, ADL, Recreation and Foot related QOL. Answers are graded a score from 0-4 and a normalised score can be calculated for each subscale (100 is asymptomatic while 0 indicates extreme symptoms).
    Time Frame
    0weeks, 20weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: >18 years old (legally able to self-sign consent) Able to stand independently Biochemically confirmed Diabetes with a fasting plasma glucose ≥ 7.0 mmol/L, or a random plasma glucose ≥ 11.1 mmol/L or hemoglobin A1c (HbA1c) level ≥ 6.5% Ulcers will be below the level of the malleoli, excluding those confined to the interdigital web space Cross-sectional area of the index ulcer should be 50- 1000 mm2 Wagner stage 2-3 Not active infection according to the Infectious Diseases Society of America guidelines Exclusion criteria: Severe cognitive impairment or severe comorbidity, which may impair ability to adhere to intervention plan, e.g. severe dementia, poor cardiopulmonary reserve requiring home oxygen, daily hemodialysis etc. Evidence of active infection Recent revascularization procedure (<12 weeks) Recently received medication/intervention which might affect cell proliferation (eg chemotherapy, radiotherapy etc) Allergy to dressing, adhesives or antibiotics Incapable to understand the study protocol or provide written informed consent
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Samuel KK Ling, MBChB
    Phone
    35052010
    Email
    samuel-kk-ling@alumni.cuhk.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gloria Chan
    Phone
    35052010
    Email
    gloriachan@cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Samuel KK Ling, MBChB
    Organizational Affiliation
    CUHK
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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