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Clinical Trials/NCT06889038
NCT06889038CompletedNot Applicable

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)

Al-Zaytoonah University of Jordan1 site in 1 country40 target enrollmentStarted: June 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Ulcer volume using Saline injection method
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
55 Years to 70 Years (Adult, Older Adult)
Sex
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

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

Arms & Interventions

control

Active Comparator

topical medication

Intervention: traditional treatment (Other)

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

Intervention: Hyperbaric oxygen therapy combined with polarized light therapy (Other)

Outcomes

Primary Outcomes

Ulcer volume using Saline injection method

Time Frame: 4 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hanan Hosny M Battesha

associate professor

Al-Zaytoonah University of Jordan

Study Sites (1)

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