Diabetic Foot UlcerNCT02452086
Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
A study testing Low Level Laser(Ga-As) in people with Diabetic Foot Ulcer, run by Tarbiat Modarres University at 1 site in Iran.
Trial summary
The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (ABI) in ischemic diabetic foot… Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Low Level Laser(Ga-As)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteIran
- Study dates
- Jun 2013to Feb 2015
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ischemic diabetic foot ulcer
- Wagner classification DFU 2
- 0.5<ABI<0.9
- Mild to moderate diabetic neuropathy
Who cannot join
- Fracture in a lower limb
- A severe infection
- A malignancy
- Kidney failure
- Skin diseases
- Osteomyelitis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Level Laser With Ga-As (904 nm) on Expression of Angiogenic Factors (VEGF, VEGF Receptor-2,NO, HIF-1α), Oxygen Saturation of Peripheral Blood and Wound Surface Area in Ischemic Diabetic Foot Ulcers
The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser Therapy(LLLT).
Read the detailed description
Defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat, A decrease of angiogenic factor expression such as Vascular Endothelial Growth Factor(VEGF) and its receptors is involved in angiogenesis inhibition in diabetic ulcers. LLLT as a therapeutic treatment modality can effect on release of these factors and angiogenesis in wound site.
The purpose of this study is to examine the changes of factors including VEGF, VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area in ischemic diabetic foot ulcers after LLLT, Therefore, the investigators can evaluate molecular process of angiogenesis, as a mechanism of useful effects of LLLT.
In order to patients with ischemic diabetic foot ulcers(DFU) assigned into LLLT with Ga-As(904 nm) laser and placebo groups and will be treated for 12 sessions, every other day. On the first and last (twelfth) treatment session, before and after intervention, Blood sample are taken from all patients in the both groups for VEGF, VEGFreceptor-2, NO and HIF-1α measurement. Wound surface area and oxygen saturation of peripheral blood and ankle-brachial index (ABI) are measured at first and twelfth treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Low Level Laser(Ga-As), Placebo
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser(Ga-As)Device
Also called LLLT
Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2
PlaceboProcedure or surgery
Also called Placebo low level laser therapy
LLLT with zero intensity
| Study group | Role | What they receive |
|---|---|---|
| Low Level Laser Therapy | Active comparator | In laser therapy group, group who received interventions was the patients received laser with 2 Joule/centimeters2, 90 milliwatt
, 3 days/week, for 4 weeks (12 sessions) Receives: Device: Low Level Laser(Ga-As) |
| Placebo | Placebo comparator | In the placebo group, the treatment procedure was the same as that the LLLT group, but the laser light was off and Guiding light was laser was on Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml)
measured from serum in initial and end sessions.
Measured: Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary outcomes (3)
Wound surface area(cm2)
Measured: Change from Baseline in wound surface area at 2 and 4 weeks
Oxygen saturation of peripheral blood
Measured: Change from Baseline with pulse oximeter at 2 and 4 weeks
Ankle Brachial Index(ABI)
Measured: Change from Baselineat 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study startJun 2013
- Primary completionNov 2014
- Study completionFeb 2015
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 Diabetic Foot UlcerStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarbiat Modarres University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, giti torkaman, Tarbiat Modarres University
- Investigators
- Giti Torkaman, PHD, Study director, Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452086
- Sponsor's protocol ID
- D52.2567
- Status last verified
- May 2015
- First submitted
- 10 May 2015
- Last updated
- 1 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Torkaman G, Hoseini-Sanati M, Hedayati M, Mofid M, Iranparvar Alamdari M. Effects of Photobiomodulation Therapy on the Expression of Hypoxic Inducible Factor, Vascular Endothelial Growth Factor, and Its Specific Receptor: A Randomized Control Trial in Patients with Diabetic Foot Ulcer. Photobiomodul Photomed Laser Surg. 2024 Apr;42(4):275-284. doi: 10.1089/photob.2023.0152. Epub 2024 Mar 27.
PubMed 38536106
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser With Ga-As (904 nm) on Expression of Angiogenic Factors (VEGF, VEGF Receptor-2,NO, HIF-1α), Oxygen Saturation of Peripheral Blood and Wound Surface Area in Ischemic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02452086
- Acronym / sponsor ID
- D52.2567
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Tarbiat Modarres UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 May 2015 (estimated)
- 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.
The purpose of this study is to examine the changes of factors including Vascular Endothelial Growth Factor(VEGF), VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area and ankle-brachial index (ABI) in ischemic diabetic foot ulcers after Low Level Laser Therapy(LLLT).
Detailed description
Defects in vessels and neovascularization makes diabetic chronic wounds difficult to treat, A decrease of angiogenic factor expression such as Vascular Endothelial Growth Factor(VEGF) and its receptors is involved in angiogenesis inhibition in diabetic ulcers. LLLT as a therapeutic treatment modality can effect on release of these factors and angiogenesis in wound site.
The purpose of this study is to examine the changes of factors including VEGF, VEGFReceptor-2, Nitric Oxide and hypoxia-inducible factor-1α (HIF-1α), measurements of oxygen saturation in peripheral blood and wound surface area in ischemic diabetic foot ulcers after LLLT, Therefore, the investigators can evaluate molecular process of angiogenesis, as a mechanism of useful effects of LLLT.
In order to patients with ischemic diabetic foot ulcers(DFU) assigned into LLLT with Ga-As(904 nm) laser and placebo groups and will be treated for 12 sessions, every other day. On the first and last (twelfth) treatment session, before and after intervention, Blood sample are taken from all patients in the both groups for VEGF, VEGFreceptor-2, NO and HIF-1α measurement. Wound surface area and oxygen saturation of peripheral blood and ankle-brachial index (ABI) are measured at first and twelfth treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Laser Therapy | Active comparator | Device: Low Level Laser(Ga-As)In laser therapy group, group who received interventions was the patients received laser with 2 Joule/centimeters2, 90 milliwatt , 3 days/week, for 4 weeks (12 sessions) |
| Placebo | Placebo comparator | Procedure: PlaceboIn the placebo group, the treatment procedure was the same as that the LLLT group, but the laser light was off and Guiding light was laser was on |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic diabetic foot ulcer
- Wagner classification DFU 2
- 0.5<ABI<0.9
- Mild to moderate diabetic neuropathy
Key exclusion criteria (7 listed)
- Fracture in a lower limb
- A severe infection
- A malignancy
- Kidney failure
- Skin diseases
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 |
|---|---|---|
| Low Level Laser(Ga-As)Also: LLLTLow level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2 | Device | Low Level Laser Therapy |
| PlaceboAlso: Placebo low level laser therapyLLLT with zero intensity | Procedure or surgery | Placebo |
Primary outcome
The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml)
Time frame: Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
measured from serum in initial and end sessions.
3 secondary outcomes
Wound surface area(cm2)
Time frame: Change from Baseline in wound surface area at 2 and 4 weeks
Oxygen saturation of peripheral blood
Time frame: Change from Baseline with pulse oximeter at 2 and 4 weeks
Ankle Brachial Index(ABI)
Time frame: Change from Baselineat 2 and 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 1 Jun 2015.
- Derived from this study: PubMed 38536106Torkaman G, Hoseini-Sanati M, Hedayati M, Mofid M, Iranparvar Alamdari M. Effects of Photobiomodulation Therapy on the Expression of Hypoxic Inducible Factor, Vascular Endothelial Growth Factor, and Its Specific Receptor: A Randomized Control Trial in Patients with Diabetic Foot Ulcer. Photobiomodul Photomed Laser Surg. 2024 Apr;42(4):275-284. doi: 10.1089/photob.2023.0152. Epub 2024 Mar 27.
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Giti Torkaman, PHD study director
Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser(Ga-As) in people with Diabetic Foot Ulcer, run by Tarbiat Modarres University at 1 site in Iran.
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 7 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 1 Jun 2015. 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 Iran. 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. Some participants in this study may receive a placebo. 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?
The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml) (time frame: Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks). 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 NCT02452086, 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 1 Jun 2015.