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CompletedNCT06889038Updated Aug 22, 2025

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

An interventional study of Hyperbaric oxygen therapy combined with polarized light therapy and traditional treatment in Neuropathic Diabetic Ulcer - Foot, sponsored by Al-Zaytoonah University of Jordan. Completed at 1 site in Egypt. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-22.

Sponsored by Al-Zaytoonah University of Jordan · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
55 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neuropathic Diabetic Ulcer - Foot

Keywords

  • Hyperbaric oxygen therapy
  • polarized light therapy
  • neuropathic foot ulcer
03

In context

Lead sponsor

Al-Zaytoonah University of Jordan is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • chronic obstructive pulmonary disease, malignancy
  • cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
  • chronic peripheral arterial disease.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • 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

  • Active comparator
    control

    topical medication

    Other: traditional treatment

Interventions

  • OtherHyperbaric 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

  • Othertraditional treatment

    topical medication

06

What researchers measure

Primary outcomes

  1. Ulcer volume using Saline injection method

    Time frame: 4 weeks

Secondary outcomes

  1. Tcpo2 at ulcer edge using Pulse Oximeter

    Time frame: 4 weeks

  2. Emg pre and at end (Sensory NCS (Sural nerve)

    Time frame: 4 weeks

07

Study locations

1 site
  • Modern University For Technology and Information
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06889038
Lead sponsor
Al-Zaytoonah University of Jordan
Responsible party
Hanan Hosny M Battesha (associate professor, Al-Zaytoonah University of Jordan) — Principal investigator
First posted
Mar 21, 2025
Start date
Jun 1, 2025
Primary completion
Jul 15, 2025
Completion
Aug 1, 2025
Last update
Aug 22, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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