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.: PACTR201909767694782 Date of Approval: 27/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Topical insulin on wound healing
Official scientific title Evaluation of the effect of Topical Insulin on wound healing in diabetic and non-diabetic patients: a clinical controlled trial in Minia District, Egypt
Brief summary describing the background and objectives of the trial The wound healing process is not only complex but also fragile, and it is susceptible to interruption or failure leading to the formation of non-healing chronic wounds. Factors that contribute to non-healing chronic wounds are diabetes, venous or arterial disease, infection, and metabolic deficiencies of old age.Diabetic wounds heal slowly and can worsen rapidly, so they require close monitoring.This delay in wound healing has been associated with increased morbidity and mortality rates in this patient population.Previous studies have reported a wound healing effect of both systemic and local insulin through improving the formation of blood vessels and increasing fibrosis. Thus, the present study aimed at evaluating and compare between the effect of topical short and long acting Insulin in healing of both diabetic and non diabetic wounds.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/09/2016
Actual trial start date 01/08/2017
Anticipated date of last follow up 01/09/2017
Actual Last follow-up date 01/08/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL https://jabps.journals.ekb.eg/article_197290.html
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 Non-randomised Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard treatment of wounds Twice daily until complete recovery application of a topical antiseptic, wound healing preparation and a topical antibiotic 20 Active-Treatment of Control Group
Experimental Group short acting insulin twice daily until complete recovery Topical application of short acting insulin solution + standard treatment 20
Experimental Group long acting insulin Twice until complete recovery topical application of long acting insulin solution 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age: 18-70 years 2. Patients with pressure ulcers, post-operative surgical wounds, diabetic ulcer, or any type of wounds with classical signs and symptoms. 3. Patients with wound size less than 25 cm². 1. Patients with infected wounds. 2. Patients older than 70 years old or younger than 18 years old. 3. Immunocompromised patients 4. Pregnant patients 5. Patients suffering from osteomyelitis. 6. Patients presenting with varicose ulcer. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 01/05/2018 The commision on the Ethics of Scientific Research
Ethics Committee Address
Street address City Postal code Country
Faculty of Pharmacy, Minia univeristy Minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete wound healing every week
Primary Outcome rate of recovery every week
Primary Outcome Pain every week
Secondary Outcome scaring every week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia Univeristy Hospital Kornich street Minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Radwa Mansour Minia, Shalaby sarofeem, Block 22 Minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia University Aswan agricultural road Minia 61111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Ahmed Kamal Faculty of Medicine, Minia Univeristy Minia 61111 Egypt
Heba Fathy Mansour Faculty of Pharmacy, Minia Univeristy Minia 61111 Egypt
Dr. AlShaimaa Faissal Fadel Ahmed Faculty of Pharmacy, Minia University Minia 61111 Egypt
Radwa Mohamed Mansour Mohamed Minia Univeristy Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Fathy drhf2002@yahoo.com 00201202505200 Minia University, Faculty of Pharmacy
City Postal code Country Position/Affiliation
Minia 61111 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Radwa Mansour radwamansour81@yahoo.com +201093674495 Minia Univeristy
City Postal code Country Position/Affiliation
Minia 61111 Egypt Master student
Role Name Email Phone Street address
Public Enquiries AlShaimaa Ahmed shffa@outlook.com 00201020018842 Minia university, faculty of Pharmacy
City Postal code Country Position/Affiliation
Minia 61111 Egypt Lecturer Department of Pharmacology and Toxicology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary of results Clinical Study Report,Study Protocol 6 month open study all types of data permitted permission requested from Minia University
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