Vibration Enhances Diabetic ULCER Healing

NCT04275804 | Unknown DMC

• 1 other identifier: CUHK
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Foot Ulcer

Keywords

Vibration; Whole Body Vibration; Low Magnitude High Frequency Vibration; Biophysical Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  0weeks, 2weeks, 8weeks, 14weeks, 20weeks, 56weeks

Secondary Outcomes (5)

• Time (days) to healing

  up to 56 weeks

• Incidence of amputation

  up to 56 weeks

• Incidence of secondary infection

  up to 56 weeks

• Perfusion

  0weeks, 20weeks

• Foot function

  0weeks, 20weeks

Study Arms (2)

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.

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.

Device: Low Magnitude High Frequence Vibration Platform

Interventions

Low Magnitude High Frequence Vibration Platform DEVICE

with low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement \<0.1mm)

Vibration group: conventional dressing and LMHFV

Conventional Dressing OTHER

Alternate Day Dressing

Control group: conventional dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Samuel KK Ling, MBChB

  CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel KK Ling, MBChB

CONTACT

35052010; samuel-kk-ling@alumni.cuhk.net

Gloria Chan

CONTACT

35052010; gloriachan@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 19, 2020
• Study Start: January 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share