Helium-Neon Laser Therapy Versus Infrared Laser Therapy in Treating Patients With Diabetic Foot Ulcer
Primary Purpose
Diabetic Mellitus, Laser
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Helium Neon Laser
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Mellitus
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study group
Control group
Arm Description
Helium Neon Laser
No intervention
Outcomes
Primary Outcome Measures
Ulcer surface area
Secondary Outcome Measures
Full Information
NCT ID
NCT03338517
First Posted
November 5, 2017
Last Updated
November 8, 2017
Sponsor
Ahlia University
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT03338517
Brief Title
Helium-Neon Laser Therapy Versus Infrared Laser Therapy in Treating Patients With Diabetic Foot Ulcer
Official Title
A Randomized Controlled Trial Comparing Helium-Neon Laser Therapy and Infrared Laser Therapy in Patients With Diabetic Foot Ulcer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 4, 2016 (Actual)
Primary Completion Date
May 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahlia University
Collaborators
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Mellitus, Laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
Helium Neon Laser
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Helium Neon Laser
Primary Outcome Measure Information:
Title
Ulcer surface area
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sayed A A Tantawy
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Helium-Neon Laser Therapy Versus Infrared Laser Therapy in Treating Patients With Diabetic Foot Ulcer
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