Diabetic Foot UlcerVIBEDULCERNCT04275804
Vibration Enhances Diabetic ULCER Healing
A study testing Low Magnitude High Frequence Vibration Platform and Conventional Dressing in people with Diabetic Foot Ulcer, run by Chinese University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Low Magnitude High Frequence Vibration Platform and Conventional Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Enhancement of Diabetic Foot Ulcer Healing Using Low-Magnitude High-Frequency Vibration Treatment - A Randomised Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Low Magnitude High Frequence Vibration Platform, Conventional Dressing
- Keywords
- Vibration, Whole Body Vibration, Low Magnitude High Frequency Vibration, Biophysical Intervention
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Magnitude High Frequence Vibration PlatformDevice
with low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement <0.1mm)
Conventional DressingOther
Alternate Day Dressing
| Study group | Role | What they receive |
|---|---|---|
| Control group: conventional dressing | Active comparator | 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. Receives: Other: Conventional Dressing |
| Vibration group: conventional dressing and LMHFV | Experimental | 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. Receives: Device: Low Magnitude High Frequence Vibration Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0weeks, 2weeks, 8weeks, 14weeks, 20weeks, 56weeks
Secondary outcomes (5)
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.
Measured: up to 56 weeks
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.
Measured: up to 56 weeks
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.
Measured: up to 56 weeks
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)
Measured: 0weeks, 20weeks
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).
Measured: 0weeks, 20weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Jan 2022 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel KK Ling, Chinese University of Hong Kong
- Investigators
- Samuel KK Ling, MBChB, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275804
- Sponsor's protocol ID
- CUHK
- Acronym
- VIBEDULCER
- Status last verified
- Jul 2021
- First submitted
- 13 Feb 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Diabetic Foot Ulcer Healing Using Low-Magnitude High-Frequency Vibration Treatment - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04275804
- Acronym / sponsor ID
- VIBEDULCER / CUHK
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Vibration, Whole Body Vibration, Low Magnitude High Frequency Vibration, Biophysical Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: conventional dressing | Active comparator | Other: Conventional DressingAlternate 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. |
| Vibration group: conventional dressing and LMHFV | Experimental | Device: Low Magnitude High Frequence Vibration PlatformAlternate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Magnitude High Frequence Vibration Platformwith low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement <0.1mm) | Device | Vibration group: conventional dressing and LMHFV |
| Conventional DressingAlternate Day Dressing | Other | Control group: conventional dressing |
Primary outcome
Ulcer size
Time frame: 0weeks, 2weeks, 8weeks, 14weeks, 20weeks, 56weeks
• 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.
5 secondary outcomes
Time (days) to healing
Time frame: up to 56 weeks
Incidence of amputation
Time frame: up to 56 weeks
Incidence of secondary infection
Time frame: up to 56 weeks
Perfusion
Time frame: 0weeks, 20weeks
Foot function
Time frame: 0weeks, 20weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel KK Ling, MBChB principal investigator
CUHK
Questions about this trial
What is this clinical trial studying?
A study testing Low Magnitude High Frequence Vibration Platform and Conventional Dressing in people with Diabetic Foot Ulcer, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel KK Ling, MBChB (35052010, samuel-kk-ling@alumni.cuhk.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer size (time frame: 0weeks, 2weeks, 8weeks, 14weeks, 20weeks, 56weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.