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Helium-Neon Laser Therapy Versus Infrared Laser Therapy in Treating Patients With Diabetic Foot Ulcer

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ClinicalTrials.gov Identifier: NCT03338517
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Dr Sayed Tantawy, Ahlia University

Brief Summary:

Background: Diabetic patients are frequently showed with foot ulceration as a common complication which increases to 20% in admission. Low-level laser therapy is used to control foot ulcer, but there is very limited data to compare the effects of Helium-Neon Laser therapy (HNLT) and Infrared Laser therapy (ILT) on diabetic foot ulcer.

Objectives: This study aimed to compare the effects of (HNLT) and (ILT) on diabetic foot ulcer.

Methods: Sixty-five patients with diabetic foot ulcer (51 males and 14 females) aged 50-60years. The participants were classified randomly to two groups, Helium-Neon Laser therapy (HNLT) and Infrared Laser therapy (ILT) groups. HNLT group received medical treatment with Helium-Neon Laser therapy and ILT group received medical treatment with Infrared Laser therapy for 8 weeks. Ulcer surface area was assessed using a sheet of cellophane paper at the beginning of the study, after four weeks, and after eight weeks at the end of the study.


Condition or disease Intervention/treatment Phase
Diabetic Mellitus Laser Other: Helium Neon Laser Not Applicable

Detailed Description:

The study was carried out after obtaining ethical approval from the Department of surgery, Cairo University Hospitals, Egypt. Patients with varying stages of diabetic foot ulcers in the hospital were screened and included in the study. 65 diabetic patients with Grade I and II ulcers were selected according to Wagner classification, ages ranged between 50 to 60 years of age, BMI of 30 free from any metabolic-related medical conditions such as nephropathy, cardiomyopathy, recent myocardial infarction and pulmonary problems. Patients were randomized into two groups; Group (I) who received medical treatment with Helium-Neon Laser therapy (HNLT), (ASA Medical laser device (manufactured by ASA Terza- Via Alessandro, Italy) and Group (II) who received medical treatment with Infrared Laser therapy (ILT), (PHYACTION 792/796 manufactured in The Netherlands by Uniphy BV). The nature of the therapy was described and explained to the patient. A written informed consent was obtained prior to implementation of the study. Patients were subjected to detailed medical examination. Glucosylated Homoglobin (HbA1c) was obtained for patient screening.

Outcome measures Ulcer surface area was calculated by getting the impression of the ulcer floor using a sheet of cellophane paper. The imprint of the ulcer floor is transferred to graphing paper where ulcer size was plotted and diameter was recorded. Ulcer size was measured at the beginning of the study, after 4 weeks, and after 8 weeks at the end of study.

The position of patient was a comfortable position with disclosure of the affected foot. Transparent plastic films were double sterilized and directly placed flat and connected to the skin at the ulcer area with nullifing any motion or misrepresentation of the affected foot. The margins of the ulcer were followed by the same investigator to set up the measurements reliability16.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Group (I) who received medical treatment with Helium-Neon Laser therapy (HNLT), (ASA Medical laser device (manufactured by ASA Terza- Via Alessandro, Italy) and Group (II) who received medical treatment with Infrared Laser therapy (ILT), (PHYACTION 792/796 manufactured in The Netherlands by Uniphy BV). The nature of the therapy was described and explained to the patient.
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Helium-Neon Laser Therapy and Infrared Laser Therapy in Patients With Diabetic Foot Ulcer
Actual Study Start Date : August 4, 2016
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : November 3, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Study group
Helium Neon Laser
Other: Helium Neon Laser
No Intervention: Control group
No intervention



Primary Outcome Measures :
  1. Ulcer surface area [ Time Frame: 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with Grade I and II ulcers were selected according to Wagner classification ages ranged between 50 to 60 years of age, BMI of 30

Exclusion Criteria:

  • nephropathy, cardiomyopathy, recent myocardial infarction and pulmonary problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338517


Sponsors and Collaborators
Ahlia University
Cairo University
Investigators
Study Director: Sayed A A Tantawy Cairo University

Responsible Party: Dr Sayed Tantawy, Associate Professor, Ahlia University
ClinicalTrials.gov Identifier: NCT03338517     History of Changes
Other Study ID Numbers: REC/012/001255
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases