Clinical trial NCT02452086: Low Level Laser Therapy and Expression of VEGF, NO, VEGFR-2, HIF-1α in Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: Tarbiat Modarres University
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic diabetic foot ulcer
* Wagner classification DFU 2
* 0.5\<ABI\<0.9
* Mild to moderate diabetic neuropathy

Exclusion Criteria:

* Fracture in a lower limb
* A severe infection
* A malignancy
* Kidney failure
* Skin diseases
* Osteomyelitis
* Pregnancy

Primary outcomes:
measure: The blood serum level of VEGF(pg/ml), VEGFR-2(pg/ml), HIF-1α(pg/ml) and NO (pg/ml)
timeFrame: Change from Baseline in serum level of VEGF, VEGFR-2, HIF-1α and NO at 4 weeks
Secondary outcomes:
measure: Wound surface area(cm2)
timeFrame: Change from Baseline in wound surface area at 2 and 4 weeks
measure: Oxygen saturation of peripheral blood
timeFrame: Change from Baseline with pulse oximeter at 2 and 4 weeks
measure: Ankle Brachial Index(ABI)
timeFrame: Change from Baselineat 2 and 4 weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tarbiat Modares University
Study officials:
affiliation: Professor of Physical Therapy, Physical Therapy Department, Faculty of Medical Sciences, Tarbiat Modares Univercity
name: Giti Torkaman, PHD
role: STUDY_DIRECTOR
References: