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Vibration Enhances Diabetic ULCER Healing

NCT04275804 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2021-07-28

No results posted yet for this study

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

Interventions

DEVICE

Low Magnitude High Frequence Vibration Platform

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

OTHER

Conventional Dressing

Alternate Day Dressing

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Samuel KK Ling, MBChB · CUHK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-03-30
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275804 on ClinicalTrials.gov