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

Hyperbaric Oxygen Therapy Combined With Polarized Light Therapy Effect on Neuropathic Foot Ulcer Regarding Transcutaneous Oxygen Saturation (TcpO2) and Healing Rate ( A Randomized Control Study)

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Diabetic Ulcer - Foot
• Intervention / Treatment: Other: Hyperbaric oxygen therapy combined with polarized light therapy; Other: traditional treatment

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Modern University for technology and information

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; patients will evaluated to be fit for HBO therapy to ensure cardiac ejection fraction over 50% and chest CT to ensure chest free from any pathology	Other: Hyperbaric oxygen therapy combined with polarized light therapy; Optimum regime of therapy increase healing rate of neuropathic foot ulcer is a challenge for researchers to save patient normal life
Active Comparator: control; topical medication	Other: traditional treatment; topical medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ulcer volume using Saline injection method	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Zaytoonah University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): July 15, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hyperbaric oxygen therapy; polarized light therapy; neuropathic foot ulcer
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Leg Ulcer; Foot Diseases; Ulcer; Foot Ulcer
• Other Study ID Numbers: Hyperbaric oxygen therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No