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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level Laser(Ga-As) | Device | Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wound surface area(cm2) | Change from Baseline in wound surface area at 2 and 4 weeks | |
| Oxygen saturation of peripheral blood | Change from Baseline with pulse oximeter at 2 and 4 weeks | |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giti Torkaman, PHD | Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tarbiat Modares University | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38536106 | Derived | 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. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Placebo | Procedure | LLLT with zero intensity |
|
|
| Ankle Brachial Index(ABI) |
| Change from Baselineat 2 and 4 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |