NCT06688708

Long-term Effects of Using a Novel Orthotic Insole for Tactile Stimulation in Diabetic Peripheral Neuropathy and Follow-up

Completed NA Last updated 20 November 2024

What this trial tests

NA trial testing Using vibrating foot orthosis with tactile stimulation in Diabetic Peripheral Neuropathy Type 2 in 55 participants. Completed in 29 December 2023.

Timeline

12 June 2023

Primary endpoint
30 November 2023

29 December 2023

Quick facts

Lead sponsor	Srinakharinwirot University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	55
Start date	12 June 2023
Primary completion	30 November 2023
Estimated completion	29 December 2023
Sites	1 location across Thailand

Drugs / interventions tested

• Using vibrating foot orthosis with tactile stimulation
• Using vibrating foot orthosis without tactile stimulation

Conditions studied

• Diabetic Peripheral Neuropathy Type 2 — all drugs for Diabetic Peripheral Neuropathy Type 2 →

Sponsor

Srinakharinwirot University

Who can join

Adults 18 to 80, any sex, with Diabetic Peripheral Neuropathy Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. This study had the objectives to investigate the long-term and remaining effects of using a novel vibrating foot orthosis for tactile stimulation in diabetic peripheral neuropathy (DPN).
2. The hypothesis of this study was using the VFO in conjunction with a random square wave pulse stimulus and pseudorandom white noise via a stochastic resonance could effectively improve tactile sensitivity and reduce vibration perception threshold (VPT).
3. Participants were recruited from the HRH Princess Maha Chakri Sirindhorn Medical Centre (Srinakharinwirot University), Ongkharak, Nakhon Nayok, Thailand.
4. 64 type 2 diabetes mellitus people with mild-to-moderate peripheral neuropathy were recruited.
5. Approach to participant: use purposive sampling by direct contact the patients who match the inclusion criteria.
6. Informed Consent Process: the information sheet was provided to participants, and the researcher explained the objectives of the study, the duration of the research, the research method, the dangers or potential effects of the research, including the benefits that might arise from the research and other methods of treatment in details. The participants had enough time and opportunity to ask questions until they had a good understanding. The researchers willingly answered questions without hiding them, until they satisfied. Then, the participants had to willingly sign a consent form prior to participate in the research project with voluntary.
7. The study protocol was approved by the Human Research Ethics Committee of Srinakharinwirot University (SWUEC-661032).
8. A randomized sham-controlled trial was conducted in this study. The experiments in this study were performed in a parallel design with random allocation and a double-blind strategy (blinded participants and investigators).
9. Baseline characteristics were assessed including: muscle strength by manual muscle testing, grading by the Medical Research Council; sensation by the Semmes-Weinstein monofilament test (5.07 gauge, 10 g pressure size) with 10-site examination; peripheral neuropathy by the Michigan neuropathy screening instrument; vibratory perception by a tuning fork (a graduated Rydel-Seiffer version); body mass index; circulatory system examination by palpating dorsalis pedis and posterior tibial pulse; pathology of diabetic foot; VPT by the Vibratory Sensory Analyzer: VSA-3000 (Medoc Ltd., USA).
10. VPT values were determined as the outcome parameter.
11. Statistical methods:

* Quantitative data will be presented with median (mean) and standard deviation (SD).
* Qualitative data will be presented with numbers and percentages.
* An independent t-test will be used to compare the independent outcomes.
* A paired t-test will be used to compare the dependent outcomes.
* A repeated-measures ANCOVA will be used for between group comparisons.
* A repeated-measures ANOVA will be used for within-group comparison.
* MANCOVA will be used for analyzing the covariates' effect on the relationship between the independent grouping variables and the continuous dependent variables.
* Cohen's d will be used to determine the effect sizes.
12. Ethical Consideration (1) All participants were provided with detailed project information prior to participation in the research project.

(2) While conducting experiments, evaluating, collecting research results, a prosthetist and orthotist (PO) and a physician will be with the participants at all times to prevent possible accidents/adverse events.

(3) If there is any harm from the research, free medical treatment will be provided.

(4) During research participation, all participants have the rights to withdraw at any time without the need to give reasons.

(5) All information obtained from the research project will be kept as a secret, and will be disclosed to the public for academic benefits without the participants' name.

13\. Expectable benefits and applications

1. Using the novel VFO may lead to efficient treatment for neurorehabilitation in DPN.
2. The investigators hope that this low-cost VFO can offer advantages such as affordability, widespread use, and home-based applications.
3. The benefits of using the novel VFO that can improve tactile sensation on the plantar surface of the foot in diabetic peripheral neuropathy.
4. Employing the novel VFO can reduce VPT.
5. Using the novel VFO can help prevent diabetic foot ulceration (DFU), lessen a risk of DFU recurrence, and avoid lower limb amputation.
6. Applying the novel VFO may help restore and prolong tactile sensation.
7. Using the novel VFO may aid in slowing DPN deterioration and decreasing peripheral nervous system impairment.
8. Utilizing the VFO may help improve quality of life for DPN people.

14\. Compensations for participants

* Payment was provided for those participants who attend throughout the study.
* All participants received a custom-made foot orthosis after completing the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.