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.: PACTR202106542254817 Date of Approval: 07/06/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fenomin and Diabetic foot ulcer
Official scientific title Utility of Low Dose combination of Vitamin B (Fenomin) in the management of diabetic foot ulcer at the National Diabetes Management and Research Centre, Ghana
Brief summary describing the background and objectives of the trial As the predicted prevalence of diabetes mellitus increases, it is likely the complication rates will also increase. One major complication of diabetes is foot amputation, which often results from a non-healing ulcer that occurs because of peripheral vascular disease and peripheral neuropathy. Although there is paucity of data from Ghana on diabetic foot, available data show that diabetes mellitus is a major contributor to non-traumatic foot amputations. Therefore, any interventions for prevention or treatment that is cost effective will be most useful. Limited evidence suggests that low dose combination vitamin B may improve diabetic foot ulcer management outcomes.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Fenomin Trial
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/06/2021
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo 1 tablet daily 3 months One tablet of placebo taken daily at night plus usual care 100 Placebo
Experimental Group Fenomin 1 tab daily at night Three (3) months White odourless tablets made up of Dicalcium phosphate 300mg Cellulose F150 50mg Nicotinamide 15mg Vitamin B1HCl 12.5mg Calcium D-Pantothenate 11.0mg Silica 8mg Magnesium stearate 8mg 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult (18 years or above) Diabetes patients with University of Texas Grade 1 foot ulcers Attending the outpatient clinic of the National Diabetes Management and Research Center (Korle Bu Teaching Hospital) or Attending the outpatient clinic of the Surgical Department of the KBTH Willing to give consent Patients with diabetes and foot ulcers who are too ill to be interviewed. Ulcers that are not classified as University of Texas Grade 1 ulcers Patients who are on other Vitamin B formulations Patients who do not give consent to be part of the study Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 01/04/2021 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Harley Street Korle Bu Accra KB 77 Ghana
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 07/04/2021 College of Health Sciences Protocol and Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Harley Street, Korle Bu Accra KB 52 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome size of ulcer 2, 4, 6, 8 and 12 weeks
Secondary Outcome mean change in microalbunuria 6 and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Diabetes Management and Research Clinic Korle Bu Teaching Hospital Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor fv Supplement Ltd 59 Brewery Road, Plumstead London SE18 1NB United Kingdom Individual
COLLABORATORS
Name Street address City Postal code Country
Dr. Yacoba Atiase Department of Medicine and Therapeutics, Korle Bu Teaching Hospital Accra Ghana
Dr. Ernest Yorke Department of Medicine and Therapeutics, Korle Bu Teaching Hospital Accra Ghana
Dr. Josephine Akpalu Korle Bu Teaching Hospital Accra Ghana
Prof. Alfred Yawson Department of Community Health, UGMS, College of Health Sciences, University of Ghana Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yacoba Atiase yatiase@ug.edu.gh +233206301447 Department of Medicine and Therapeutics, Korle Bu Teaching Hospital
City Postal code Country Position/Affiliation
Accra Ghana Senior Lecturer UGMS
Role Name Email Phone Street address
Public Enquiries Kwadwo Koram kkoram@noguchi.ug.edu.gh +233204313130 Noguchi Memorial Institute for Medical Research, College of Health Sciences, University of Ghana
City Postal code Country Position/Affiliation
Legon Ghana Research Fellow
Role Name Email Phone Street address
Scientific Enquiries Kofi Bempah kb436@outlook.com +447914120175 59 Brewery Road, Plumstead
City Postal code Country Position/Affiliation
London SE18 1NB United Kingdom Collaborator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 6 months and ending 36 months following article publication Investigators who present a methodologically sound proposal and whose proposed use of the data has been approved by an independent review committee identified for this purpose
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