NCT05917249

Brief Summary

Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease in foot sensation. Therefore, the treatment of this disorder is very important.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 23, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

June 5, 2023

Last Update Submit

February 10, 2024

Conditions

Diabetic Neuropathy, Painful

Outcome Measures

Primary Outcomes (1)

  • Change of the perfusion index at the end of the first session compared to baseline readings.

    the perfusion index readings will be taken before the first session and set as baseline reading and after the first session and the change will be calculated.The Masimo SET "Mighty-Sat Fingertip Pulse Oximetry" (Masimo Corporation, Irvine, CA, USA model 9900) was attached to the big toe of each patient. the reading will be the the mean of three measurements of perfusion index (PI) taken at one-minute intervals.

    40 minutes

Secondary Outcomes (4)

  • Visual Analogue Scale

    2 months

  • Tactile sensation of the sole

    2 months

  • Analgesic effect

    2 months

  • The total remission rate

    2 months

Study Arms (1)

interventional

EXPERIMENTAL
Device: Capacitive-Resistive Noninvasive Radiofrequency

Interventions

Capacitive-Resistive Noninvasive RadiofrequencyDEVICE

The two passive plates were under the back of the patient. The active capacitive plates of the machine (CAPENGERY, C200, Spain) will be applied initially for 20 minutes over the sole of both feet, with the machine adjusted on the A-thermal mode (37 oC). During the remaining 20 minutes, active capacitive plates are relocated over femoral vessels at the femoral triangle with the machine adjusted on the frank thermal mode (41 oC).

Also known as: TECAR
interventional

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70 years
  • Type II DM with DPN (grade I-II) in lower limbs
  • Duration of DM\>5 years
  • Visual Analog Scale (VAS) ≥3 in the feet
  • Sensory impairments in the lower extremities

You may not qualify if:

  • Patient with previous stenting or surgical intervention of lower limb arterial system.
  • Patients with previous history of DVT.
  • Pregnancy
  • Diabetic infectious wound
  • Cardiac pacemaker presence
  • Severe liver and kidney dysfunction or history of heart and lung disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicine

Cairo, 1772, Egypt

Location

Related Publications (2)

  • Niajalili M, Sedaghat M, Reazasoltani A, Akbarzade Baghban AR, Sadat Naimi S. [Effect of Capacitive Tecar Therapy on Foot Pain and Tactile Sensation in Patients With Type 2 Diabetes (Persian)]. Archives of Rehabilitation. 2020; 21(3):304-319. https://doi.org/10.32598/RJ.21.3.60.5

    BACKGROUND

  • Tashiro Y, Hasegawa S, Yokota Y, Nishiguchi S, Fukutani N, Shirooka H, Tasaka S, Matsushita T, Matsubara K, Nakayama Y, Sonoda T, Tsuboyama T, Aoyama T. Effect of Capacitive and Resistive electric transfer on haemoglobin saturation and tissue temperature. Int J Hyperthermia. 2017 Sep;33(6):696-702. doi: 10.1080/02656736.2017.1289252. Epub 2017 Feb 19.

    PMID: 28139939BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Mohamed Abdelrauof, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Waleed Al-Hamimy, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 23, 2023

Study Start

June 7, 2023

Primary Completion

January 1, 2024

Study Completion

January 30, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

EG(1)