Diabetic Foot Ulcer
Conditions
Brief summary
This study was conducted to evaluate the effect of silver nanoparticle phonophoresis on accelerating chronic diabetic foot ulcer healing.
Detailed description
Silver nanoparticle phonophoresis enhances anti-inflammatory actions by reducing pro-inflammatory cytokines. The effectiveness of topical nanoparticles is constrained due to rapid inactivation by biological debris, making phonophoresis an optimal delivery method, which uses low-intensity ultrasound to penetrate deeply into tissues, enhancing permeability and accelerating healing. The study aimed to evaluate the effect of silver nanoparticle phonophoresis on improving healing in chronic diabetic foot ulcers.
Interventions
DEVICEActive silver nanoparticle phonophoresis
A nanosilver gel was directly introduced as the primary coupling interface. An ultrasound device was utilized at a low intensity of 0.5 W/cm², for 1 minute of active sonication per 1 cm² of ulcer size, 2 times per week for 3 weeks
DEVICEIsolated low-intensity pulsed ultrasound therapy
Patients received low-intensity pulsed ultrasound therapy utilizing standard, aqua-gel. After application of ultrasound, the wound bed was dried, and the silver nanoparticle gel was topically applied. It was applied for 2 times per week for 3 weeks.
OTHERStandard wound care
It included standard nursing care (daily dressing and debridement if needed)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Type1 or Type 2 Diabetes Mellitus with chronic foot ulcer. * Clear clinical documentation of superficial infection.
Exclusion criteria
* Deep bone osteomyelitis. * Peripheral gangrene. * Severe local ischemia. * Pregnancy. * Systemic multi-organ failure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer Surface Area | 3 weeks | It was calculated using digital planimetry. A calibration marker was positioned adjacent to the border. The camera of a smartphone having the validated IMITO Wound mobile application was maintained at a distance of 20-30 cm to record the photo and extract ulcer surface area. |
| Ulcer Volume Displacement Evaluation | 3 weeks | It was evaluated by the sterile fluid-injection method. Sterile saline solution was injected into the ulcer cavity via a calibrated syringe. The volume of saline injected was measured to determine volumetric dimensions. |
Countries
Egypt
Contacts
STUDY_DIRECTORDoaa A Aly
Cairo University
STUDY_CHAIREman M Othman, As.professor
Cairo University
Outcome results
None listed