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

NCT06889038 | Completed DMC

• 1 other identifier: Hyperbaric oxygen therapy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Diabetic Ulcer - Foot

Keywords

Hyperbaric oxygen therapy; polarized light therapy; neuropathic foot ulcer

Outcome Measures

Primary Outcomes (1)

• Ulcer volume using Saline injection method

  4 weeks

Secondary Outcomes (2)

• Tcpo2 at ulcer edge using Pulse Oximeter

  4 weeks

• Emg pre and at end (Sensory NCS (Sural nerve)

  4 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

control

ACTIVE COMPARATOR

topical medication

Other: traditional treatment

Interventions

Hyperbaric oxygen therapy combined with polarized light therapy OTHER

Optimum regime of therapy increase healing rate of neuropathic foot ulcer is a challenge for researchers to save patient normal life

study group

traditional treatment OTHER

topical medication

control

Eligibility Criteria

• Age: 55 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al-Zaytoonah University of Jordan: lead

Study Sites (1)

Modern University For Technology and Information

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: June 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: August 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

EG (1)