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COMPLETED
NCT07790757
PHASE1

Efficacy of Topical Insulin Gel as a Coupling Medium in Phonophoresis-Assisted Physiotherapy vs Liposomal Insulin in Management of Joint Inflammation

Sponsor: Deraya University

View on ClinicalTrials.gov

Summary

Although most clinical applications of topical insulin have centered on diabetic wound healing, emerging evidence in animal models supports its use in musculoskeletal inflammation. In osteoarthritic models, insulin was shown to downregulate cartilage-degrading enzymes (MMP-1, MMP-13, ADAMTS4) in synovial fibroblasts by activating the insulin receptor and PI3K/Akt signaling pathways, indicating direct synovial anti-inflammatory effects3. From a physiotherapeutic perspective, therapeutic ultrasound facilitates deeper tissue heating and enhances local circulation, potentially improving the dermal and transdermal absorption of topically applied agents. Therefore, using insulin in gel form as a coupling medium offers dual benefits: enhanced drug delivery via ultrasound and localized modulation of inflammatory processes in joints and soft tissues. This synergy could lead to superior pain relief and functional recovery compared to standard ultrasound gel. * Primary Objective: To evaluate the effect of topical nano-insulin gel on pain reduction and functional improvement compared to standard insulin gel combined with the Phonophoresis technique. * Secondary Objectives: To assess quality of life markers as changes in joint mobility, strength, and incidence of local/systemic adverse effects.

Official title: Efficacy of Topical Insulin Gel as a Coupling Medium in Phonophoresis-Assisted Physiotherapy vs Liposomal Insulin in Management of Joint Inflammation: A Randomized, Double-Blind Controlled Trial

Key Details

Gender

All

Age Range

40 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-07-01

Completion Date

2026-02-01

Last Updated

2026-08-27

Healthy Volunteers

Yes

Interventions

DRUG

Insulin

Topical insulin gel (2 IU/g) applied with phonophoresis technique

DRUG

nano-insulin gel

Transferosomes were formulated by the conventional handshaking method using Phos-pholipid (soylecithin) and surfactant (sodium deoxycholate) are mixed with chloroform in the ratio 1:1:1

RADIATION

phonophoresis and ultasound

combination of ultrasound and phonophoresis without insulin

Locations (1)

Deraya university, physiotherapy clinics

Minya, Egypt