NCT07395895

Brief Summary

This study is designed as a randomized, double-blind, placebo-controlled clinical trial with two parallel groups. All participants will receive a standardized physical therapy rehabilitation program. Participants will be randomly allocated into either a study group receiving metformin iontophoresis or a control group receiving placebo iontophoresis. Both participants and outcome assessors will be blinded to group allocation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2026

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 1, 2026

Last Update Submit

February 1, 2026

Conditions

Osteoarthritis in Postmenopausal Women

Keywords

Metformin gelIontophoresisPhysical Therapy RehabilitationOsteoarthritisPostmenopausal Women

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    assessed using the Visual Analog Scale.

    at baseline, after 6 weeks and after 12 weeks

  • Functional status

    assessed using the WOMAC index

    at baseline, after 6 weeks and after 12 weeks

Study Arms (2)

Metformin Iontophoresis

ACTIVE COMPARATOR
Drug: Metformin gel Iontophoresis

Iontophoresis Combined with Physical Therapy Rehabilitation

ACTIVE COMPARATOR
Device: Iontophoresis

Interventions

Metformin gel IontophoresisDRUG

Metformin gel 2% Iontophoresis Combined with Physical Therapy Rehabilitation

Metformin Iontophoresis
IontophoresisDEVICE

Iontophoresis with neutral gel Combined with Physical Therapy Rehabilitation

Iontophoresis Combined with Physical Therapy Rehabilitation

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal Women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women aged 50-70 years.
  • Clinical and radiographic diagnosis of knee osteoarthritis according to the American College of Rheumatology criteria.
  • Radiographic severity classified as Kellgren-Lawrence grade II or III.
  • Chronic knee pain for a duration of at least 3 months.
  • Pain intensity ≥4 on the Visual Analog Scale.
  • Ability to ambulate independently with or without assistive devices.
  • Ability to understand and follow instructions.
  • Willingness to participate and provide written informed consent.

You may not qualify if:

  • Severe knee osteoarthritis (Kellgren-Lawrence grade IV).
  • History of knee surgery or intra-articular injections within the previous 6 months.
  • Presence of inflammatory rheumatic diseases such as rheumatoid arthritis or gout.
  • Neurological disorders affecting lower limb function.
  • Uncontrolled metabolic, cardiovascular, or systemic diseases.
  • Current or recent use of metformin or other antidiabetic medications.
  • Skin lesions, infections, or hypersensitivity at the iontophoresis site.
  • Contraindications to electrotherapy such as pacemakers or implanted electronic devices.
  • Body mass index ≥35 kg/m².
  • Participation in another clinical trial within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University in Cairo

Cairo, 11829, Egypt

Location

Related Publications (1)

  • 1. Bannuru RR, Osani MC, Vaysbrot EE, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis and Cartilage. 2019;27(11):1578-1589. 2. Kolasinski SL, Neogi T, Hochberg MC, et al. 2020 American College of Rheumatology guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care & Research. 2020;72(2):149-162. 3. Quicke JG, Foster NE, Ogollah RO, et al. Supervised exercise therapy for knee osteoarthritis: A randomized controlled trial. Ann Rheum Dis. 2022;81(3):336-343. 4. Wang Y, Hussain SM, Wluka AE, et al. Effect of exercise therapy on knee osteoarthritis: Systematic review and meta-analysis. Arthritis Res Ther. 2021;23:147. 5. Zhang W, Doherty M, Peat G, et al. EULAR evidence-based recommendations for knee osteoarthritis management. Ann Rheum Dis. 2020;79(6):685-699.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Iontophoresis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative Techniques

Central Study Contacts

‪Eman swan‬, Ph d

CONTACT

+201090111013eman.said@buc.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

March 1, 2026

Primary Completion

April 15, 2026

Study Completion

May 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)