Neuropathic Diabetic Ulcer - FootNCT06889038
Hyperbaric Oxygen Therapy Combined With Polarized Light Therapy Effect on Neuropathic Foot Ulcer
A study testing Hyperbaric oxygen therapy combined with polarized light therapy and traditional treatment in people with Neuropathic Diabetic Ulcer - Foot, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Neuropathic Diabetic Ulcer - Foot
- What is being tested?
- Hyperbaric oxygen therapy combined with polarized light therapy and traditional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- chronic obstructive pulmonary disease, malignancy
- cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
- chronic peripheral arterial disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Being tested
- Hyperbaric oxygen therapy combined with polarized light therapy, traditional treatment
- Keywords
- Hyperbaric oxygen therapy, polarized light therapy, neuropathic foot ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapy combined with polarized light therapyOther
Optimum regime of therapy increase healing rate of neuropathic foot ulcer is a challenge for researchers to save patient normal life
traditional treatmentOther
topical medication
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Hyperbaric oxygen therapy combined with polarized light therapy |
| control | Active comparator | topical medication Receives: Other: traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer volume using Saline injection method
Measured: 4 weeks
Secondary outcomes (2)
Tcpo2 at ulcer edge using Pulse Oximeter
Measured: 4 weeks
Emg pre and at end (Sensory NCS (Sural nerve)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Jun 2025
- Primary completion15 Jul 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Diabetic Ulcer - FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889038
- Sponsor's protocol ID
- Hyperbaric oxygen therapy
- Status last verified
- Aug 2025
- First submitted
- 15 Mar 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06889038
- Acronym / sponsor ID
- Hyperbaric oxygen therapy
- Conditions
- Neuropathic Diabetic Ulcer - Foot
- Keywords
- Hyperbaric oxygen therapy, polarized light therapy, neuropathic foot ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Hyperbaric oxygen therapy combined with polarized light therapypatients 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 |
| control | Active comparator | Other: traditional treatmenttopical medication |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- chronic obstructive pulmonary disease, malignancy
- cardiac pacemakers, or any disorder that lead to ulcers other than diabetes
- chronic peripheral arterial disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapy combined with polarized light therapyOptimum regime of therapy increase healing rate of neuropathic foot ulcer is a challenge for researchers to save patient normal life | Other | study group |
| traditional treatmenttopical medication | Other | control |
Primary outcome
Ulcer volume using Saline injection method
Time frame: 4 weeks
2 secondary outcomes
Tcpo2 at ulcer edge using Pulse Oximeter
Time frame: 4 weeks
Emg pre and at end (Sensory NCS (Sural nerve)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy combined with polarized light therapy and traditional treatment in people with Neuropathic Diabetic Ulcer - Foot, run by Al-Zaytoonah University of Jordan at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer volume using Saline injection method (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.