Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201910673765658 Date of Approval: 09/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title effect of pulsed electromagnetic field on endothelial function in peripheral artery disease in type 2 diabetic patient
Official scientific title Effect of Pulsed Electromagnetic Field on Lower Extremity Peripheral Artery Disease in Type 2 Diabetic Patient
Brief summary describing the background and objectives of the trial Peripheral arterial disease has an important place in health care due to its high incidence and prevalence among Diabetic patients, as well as its consequences. It was recently reported that the management of PAD is very expensive, as the current management is centered on expensive vascular surgical interventions, with high rates of recurring hospitalizations and repeat revascularization procedures. In this study, a new method will be used trying to decreasing pain intensity level and improve the endothelial function in PAD patient by using PEMF
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/11/2018
Actual trial start date 01/11/2018
Anticipated date of last follow up 01/11/2019
Actual Last follow-up date 01/11/2020
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 25
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group group A 3 sessions per week 8w patients will receive Pulsed electromagnetic field therapy over both calf muscles 15
Control Group group B 3 sessions per week 8 weeks They will have High Intensity Interval training in the form of bicycle ergometer exercise for lower limb 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Age will range from 50 to 60 years (Torres-Duran et al., 2007). - Type 2 Diabetic patients (7-10years duration) with lower extremity peripheral artery disease and has intermittent claudication and pain. - Intensity of pain: by numerical analogue scale (NAS) equal to 5 or greater. - Patient with Ankle brachial index <0.9. - BMI rang (25 to 29). - Ankle brachial index ≥ 9. - Uncontrolled diabetes mellitus. - Treatment with steroids, cancer chemotherapy. - Cardiac abnormalities or pacemakers. - Previous surgical procedure in lower extremities. - Life threatening disorders as renal failure, myocardial infarction. - Musculoskeletal disorder of lower limb. - Logistic problems to attend regular exercise training sessions. Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/11/2018 Faculty of Physical Therapy research ethics
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El- Zayat Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ankle brachial index pre and post
Primary Outcome Flow mediated dilatation pre and post
Secondary Outcome Pain intensity level secondary outcomes pre and post
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national heart institute omar toson Giza 12651 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
marwa yehia abd elhamed al obour 4th district cairo 11822 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo university 7 Ahmed El- Zayat Giza 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
wadeda hassan ahmed elzyat cairo 12613 Egypt
hamdy soliman ebn elnafes square cairo 12651 Egypt
soher shehata ahmed elzyat cairo 12613 Egypt
abeer ahmed ahmed elzyat cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator marwa yehia marwayahia06@gmail.com 00201122460536 Khalil Hamdey
City Postal code Country Position/Affiliation
Elobour 11822 Egypt Physical therapist at national heart institute
Role Name Email Phone Street address
Public Enquiries Wadeda Hassan Dr.wadida.hassan@gmail.com 00201001097571 Ahmed Elzyat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Hamdy Soliman helliwa717@gmail.com 00201001662891 Ebn elnafess
City Postal code Country Position/Affiliation
Giza 12651 Egypt consultant of cardiology national heart institute
Role Name Email Phone Street address
Scientific Enquiries soher Sehatat sohershehatarezk@gmail.com 00201224003374 AhmedElzyat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Assistant Professor of Basic Science Department Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Abeer Ahmed abeer.phth@yahoo.com 00201116013302 Ahmed Elzyat
City Postal code Country Position/Affiliation
Giza 12613 Egypt Assistant Professor of cardiovascular respiratory and geriatrics Department Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes physical therapist Study Protocol 18 month pulsed electromagnetic therapy peripheral arterial disorder
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information