Wound Healing DisorderNCT04446767
Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
A study testing polarized light and Medical Care in people with Wound Healing Disorder, run by Cairo University at 1 site in Egypt.
Trial summary
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Wound Healing Disorder
- What is being tested?
- polarized light and Medical Care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2020to 5 Sep 2020
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
- Cooperative and mentally stable patients .
Who cannot join
- Hepatic patients .
- Uncontrolled hypertension .
- Uncontrolled diabetic patients with HbA1c>8.5% .
- Neurological disorders .
- Musculoskeletal disorders that interfere with program .
- Previous history or any sign of DVT .
Trial locations and contacts
1 site in 1 country.
About this study
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer
Read the detailed description
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.
- Conditions
- Wound Healing Disorder
- Being tested
- polarized light, Medical Care
- Keywords
- diabetes, foot ulcer, polarized light, ;wound healing
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polarized lightRadiation
Also called bioptron light therapy
bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks
Medical CareOther
Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results
| Study group | Role | What they receive |
|---|---|---|
| Bioptron light therapy and medical care | Experimental | bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results Receives: Radiation: polarized light |
| medical care | Active comparator | Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results Receives: Other: Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histologic evaluation:
Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment
Measured: two months
Wound assessment
The wound surface area (ulcer size), lenghth and width will measured using Ruler technique
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Aug 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Responsible party
- Principal investigator, Mona Mohamed Taha, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446767
- Sponsor's protocol ID
- P.T REC/017/00482.
- Status last verified
- Feb 2021
- First submitted
- 28 May 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taha MM, El-Nagar MM, Elrefaey BH, Elkholy RM, Ali OI, Alkhamees N, Felaya EEE. Effect of Polarized Light Therapy (Bioptron) on Wound Healing and Microbiota in Diabetic Foot Ulcer: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Dec;40(12):792-799. doi: 10.1089/photob.2021.0175. Epub 2022 Oct 28.
PubMed 36315226
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation With Polarized Light as Adjunctive Treatment in Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT04446767
- Acronym / sponsor ID
- P.T REC/017/00482.
- Conditions
- Wound Healing Disorder
- Keywords
- diabetes, foot ulcer, polarized light, ;wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Princess Nourah Bint Abdulrahman University
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 25 Jun 2020 (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.
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer
Detailed description
Effect of Photobiomodulation With Polarized Light on wound healing and aerobic microflora in Diabetic Foot Ulcer both sexes were included and intervention will be given for two months, wound healing will be assessed by measuring the surface area and the Aerobic microflora will be isolated and controlled on the basis of bio-gram and antibiogram at the beginning and at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioptron light therapy and medical care | Experimental | Radiation: polarized lightbioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks plus medical care in the form of Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results |
| medical care | Active comparator | Other: Medical CareAppropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patients with diagnosed diabetic foot ulcer lasting at least 4 weeks ( sized from 0.5 to 2 cm
- Cooperative and mentally stable patients .
Key exclusion criteria (6 listed)
- Hepatic patients .
- Uncontrolled hypertension .
- Uncontrolled diabetic patients with HbA1c>8.5% .
- Neurological disorders .
- Musculoskeletal disorders that interfere with program .
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 |
|---|---|---|
| polarized lightAlso: bioptron light therapybioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks | Radiation | Bioptron light therapy and medical care |
| Medical CareAppropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results | Other | medical care |
Primary outcome
Histologic evaluation:
Time frame: two months
Aerobic microflora will be isolated and controlled on the basis of biogram and antibiogram at the beginning and at the end of treatment
Wound assessment
Time frame: two months
The wound surface area (ulcer size), lenghth and width will measured using Ruler technique
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 2 Mar 2021.
- Derived from this study: PubMed 36315226Taha MM, El-Nagar MM, Elrefaey BH, Elkholy RM, Ali OI, Alkhamees N, Felaya EEE. Effect of Polarized Light Therapy (Bioptron) on Wound Healing and Microbiota in Diabetic Foot Ulcer: A Randomized Controlled Trial. Photobiomodul Photomed Laser Surg. 2022 Dec;40(12):792-799. doi: 10.1089/photob.2021.0175. Epub 2022 Oct 28.
- Individual participant dataSharing planned: No
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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 polarized light and Medical Care in people with Wound Healing Disorder, run by Cairo University 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 2 inclusion and 6 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 2 Mar 2021. 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?
Histologic evaluation: (time frame: two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04446767, which also lists 1 linked publication.
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 2 Mar 2021.