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.: PACTR202207752067410 Date of Approval: 05/07/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTS OF BUERGER-ALLEN EXERCISE IN PATIENTS WITH TYPE TWO DIABETES AND CHRONIC DIABETIC FOOT ULCER
Official scientific title EFFECTS OF BUERGER-ALLEN EXERCISE IN PATIENTS WITH CHRONIC DIABETIC FOOT ULCER
Brief summary describing the background and objectives of the trial Diabetic foot is one of the most significant and devastating complications of diabetes, and is defined as a foot affected by ulceration that is associated with neuropathy and/or peripheral arterial disease of the lower limb in a patient with diabetes. Using the Buerger-Allen exercises may enhance the blood supply to the extremity, potentially leading to enhancement of healing of diabetic foot ulcer (DFU). This study aimed to assess the effects of Buerger-Allen exercises on DFU healing.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/06/2021
Actual trial start date
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 41
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Buerger Allen exercise group Three times per week for 4 weeks five cycles of Buerger-Exercises for a total of less than or equal to 50 minutes Routine wound care plus Buerger-Allen exrcises. Buerger-Allen exrcises consisted of: Position 1 (elevation): The lower extremities are elevated to a 45 to 90degree angle Position 2 (dependency): The patient sits with the feet and legs rested in a dependent position Position 3 (horizontal): the legs are placed horizontal on the bed for 3-5 minutes. 25
Control Group Routine wound care Ongoing wound care for 4 weeks It consists of : Medical care including daily dressings and drug treatment (antibiotics and insulin), 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
•Type 2 diabetes • Middle-aged adults (from 36-55 years) •Both males and females. -Chronic diabetic foot ulcer -Type 1 diabetes •Acute or critical limb ischemia •Deep ulcer with abscess, osteomyelitis, or joint sepsis. •Previous lower limb amputation. •Venous ulcer •Chronic heart failure •DVT Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 36 Year(s) 55 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 07/02/2021 Ethics Committee of Scientific reserach at the Faculty of Physical Therapy at Cairo University
Ethics Committee Address
Street address City Postal code Country
Ahmad Elzyat street, in front of Ben el Sarayat Traffic, Giza Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1-Ankle brachial index, 2-ulcer size and depth at baseline and after 4 weeks
Secondary Outcome Ulcer risk at baseline and after four weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assuit Hospital located in Assiut, Egypt. Assuit Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Abul Fotouh Assuit Assuit Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo University Giza st. Giza Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alaa Abul Fotouh Assuit Assuit Egypt
Walaa Anwar Assuit Assuit Egypt
Akram Abdel Aziz Ahmad El Zyat, Giza Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmad Ahmad ahmed.mahdy@pt.cu.edu.eg 2001007056624 13 Darb al Mwahi-Al sakkayeen--Abdeen-
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor of Cardiovasclar Physiotherapy at Cairo University
Role Name Email Phone Street address
Public Enquiries Alaa Abu El Fotoh alaa_abul_fotouh1810@yahoo.com 201068023277 Located in Assuit
City Postal code Country Position/Affiliation
Assuit Egypt Physiotherapist at Assuit Hospital
Role Name Email Phone Street address
Scientific Enquiries Ahmad Ahmad ahmed.mahdy@pt.cu.edu.eg 2001007056624 Darb el Mwahi, al sakkayeen-Abdeen
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Cardiovascular Physiotherapy at cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in diabetic foot ulcer Study Protocol Data requests can be submitted after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research
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