Ultrasonic Enhancement Delivery of Phosphodiesterase Inhibitors Nanoparticles for Diabetic Management of the Foot

NCT07690566 | Completed

• 1 other identifier: Diabetic foot
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The enhancement of cGMP levels at the wound site has shown beneficial effects in wound healing. Thus, topical or systemic application of phosphodiesterase 5 (PDE5) inhibitors, for example, sildenafil (Viagra), which is well-known for its use in the treatment of erectile dysfunction, enhanced contraction, re-epithelialization, and tensile strength of rat wounds and reduced pressure ulcer size in a few patients. In addition, Nanofibers Specifically designed for topical drug delivery enable the sustained release of therapeutic molecules, such as growth factors. This targeted approach ensures optimal cell-to-cell interactions, proliferation, and vascularization, fostering effective and controlled wound healing. Diabetic foot is Diabetic foot ulcers (DFUs) are the most common complications associated with diabetes mellitus. DFUs are displayed as open sores or wounds on the bottom of the foot as a secondary complication of diabetes mellitus (DM). DFUs are associated with significant morbidity and mortality and can subsequently lead to hospitalization and lower limb amputation if not recognized and treated on time. An immense challenge to conventional treatments is caused by the chronic nature of diabetic foot syndrome, and it has led to the emergence of nanotechnology-based therapeutics.

Conditions

Diabetic Foot

Keywords

Diabetic foot ulcer; nanofibers, Tadalafil; Phonophoresis; Therapeutic ultrasound; Chronic wound; Case report

Outcome Measures

Primary Outcomes (3)

• Number of ulcers

  counts minimum 1 and maximum 5

  6 weeks

• Ulcer Size

  measured by planimetry and unit is cm

  6 weeks

• Pain Score

  by VAS score minimum is 0 and maximum is 10

  6 weeks

Study Arms (1)

tadalafil group

EXPERIMENTAL

tadalafil nanofibers in the form of HPMC gel

Drug: Tadalafil

Interventions

Tadalafil DRUG

tadalafil nanofiber in the form of HPMC hydrogel

tadalafil group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least 30 years old.
• Presence of a DFU, Wagner 1 extending at least through the dermis provided it is below the medial aspect of the malleolus.
• The index ulcer will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot they must be more than 2 cm distant from the index ulcer.
• Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to SV1 and less than 1-year, as of the date the subject consents for study.
• Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1

You may not qualify if:

• Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
• Investigators, in the opinion of the investigator, is suspected of cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit (SV1).

Sponsors & Collaborators

• Deraya University: lead

Study Sites (1)

Deraya university, physiotherapy clinics

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: September 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 20, 2025
• Last Updated: July 8, 2026

Record last verified: 2026-07

Locations

EG (1)