NCT04275804: VIBEDULCER

Vibration Enhances Diabetic ULCER Healing

Status unknown NA Last updated 28 July 2021

What this trial tests

NA trial testing Low Magnitude High Frequence Vibration Platform in Diabetic Foot Ulcer in 106 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
30 March 2024

31 December 2024

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	106
Start date	1 January 2022
Primary completion	30 March 2024
Estimated completion	31 December 2024

Drugs / interventions tested

• Low Magnitude High Frequence Vibration Platform
• Conventional Dressing

Conditions studied

• Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Study Protocol for a Randomised Controlled Trial to Investigate the Enhancement of Diabetic Foot Ulcer Healing Using Low-Magnitude High-Frequency Vibration Treatment
   Ling SKK, Hung NCL, Cheung W, Yung PS. · · 2021 · cited 1× · DOI 10.21203/rs.3.rs-221851/v1