Hyperbaric Oxygen Therapy Combined with Polarized Light Therapy Effect on Neuropathic Foot Ulcer

Not Applicable

Not yet recruiting

• Conditions: Neuropathic Diabetic Ulcer - Foot

• Registration Number: NCT06889038
• Lead Sponsor: Al-Zaytoonah University of Jordan

Brief Summary

Neuropathic ulcers develop due to nerve damage (neuropathy), commonly seen in conditions like diabetes, leading to loss of sensation, repetitive trauma, and poor wound healing. These ulcers typically occur on weight-bearing areas, hyperbaric oxygen and polarized light therapies may have a synergistic effect, improving oxygenation, cellular activity, and overall healing outcomes in neuropathic ulcers, particularly in diabetic foot ulcers.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-15
• Study First Submitted QC: 2025-03-15
• Last Update Submitted: 2025-03-15
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-04-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• All patients had cardiac ejection fraction (CEF) 50%
• blood pressure (BP) 150/90mmHg.
• Chest X-ray was reported normal
• all patients were clinically evaluated by a specialized ear, nose, and throat (ENT) physician to ensure suitability for the hyperbaric chamber.

Exclusion Criteria

• chronic obstructive pulmonary disease, malignancy
• cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
• chronic peripheral arterial disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ulcer volume using Saline injection method	4 weeks

Secondary Outcome Measures

Name	Time	Method
Tcpo2 at ulcer edge using Pulse Oximeter	4 weeks
Emg pre and at end (Sensory NCS (Sural nerve)	4 weeks

Trial Locations

Locations (1)

Modern University For Technology and Information; 🇪🇬 Egypt, Egypt