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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202001800892609 Date of Registration: 13/01/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title CLINICAL EVALUATION OF TOPICAL SIMVASTATIN GEL FOR TREATMENT OF CHRONIC WOUNDS
Official scientific title CLINICAL EVALUATION OF TOPICAL SIMVASTATIN GEL FOR TREATMENT OF CHRONIC WOUNDS
Brief summary describing the background and objectives of the trial An open study of thirty five patients with chronic wound. Patients were randomly divided in two separate groups. In the first group 1% simvastatin anhydrous gel bases was topically administered, while the second group (standard) was treated with phenytoin 2% aerosol topical once daily. Wound healing was observed each week in both groups and wounds photographed.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2017
Actual trial start date
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants) 35
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 by using procedures such as coin-tossing or dice-rolling Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Topical application of simvastatin gel The first group was 18 patients treated with simvastatin 1% anhydrous gel and the second group was 17 patients treated with phenytoin 2% aerosol, respectively. Four weeks The first group was 18 patients treated with simvastatin 1% anhydrous gel and the second group was 17 patients treated with phenytoin 2% aerosol, respectively. All patients were followed up on weekly basis and wound status was assessed and recorded according to healing degree as: Complete healing of wound, partial healing of wound, no improvement or worsening of the condition. 18
Control Group Topical application of phenytoin aerosol four weeks All patients were followed up on weekly basis and wound status was assessed and recorded according to healing degree as: Complete healing of wound, partial healing of wound, no improvement or worsening of the condition. After 04 weeks. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Diabetic foot ulcer, venous ulcer or post-surgery wound for more than 4 weeks. ● Clean non healing wound for more than 4 weeks. ● Age group 40-60 years, both male and female. ● Uncontrolled diabetics. ● Presence of vascular impairment. ● Associated co-morbidity such as hepatic and renal diseases. ● Patients with allergy to Phenytoin or Simvastatin. ● Infected wound. ● Pregnant women. ● Patient who had an unstable psychological profile. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 05/10/2017 The commission on the ethics of scinetific research facultyof pharmacy minia university
Ethics Committee Address
Street address City Postal code Country
minia university minia 61519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome On day 14 of treatment period, simvastatin treated patients showed complete healing of wounds in eight patients (44.4%), while only four patients (23.4%) showed complete wound healing in phenytoin treated patients. day 14
Secondary Outcome At the end of the treatment period (Four weeks), complete healing was evident in 13 patients (72%) of simvastatin group and 9 patients (52.9%) in phenytoin group. Patient who showed partial healing of their wounds were 4 patients (22.2%) in the study group versus 5 patients (29.4%) in the phenytoin group (positive control). Patient who showed no improvement were 2 patients (11.7%) in the phenytoin group versus no patient in the study group. 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia university hospital minia university hospital street , kornesh road minia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Raouf Mohamed Faculty of pharmacy Minia university Minia 61519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of vascular surgery minia university hospital minia Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hamza Abdel raouf Minia University Hospital Minia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries MOHAMED RAOUF MMOHAMEDALI@KFSHRC.EDU.SA 00966591961748 ALFAISYALIA
City Postal code Country Position/Affiliation
JEDDAH Saudi Arabia Critical care pharmacist
Role Name Email Phone Street address
Principal Investigator USAMA FARGHALY US_FARGHALY@HOTMAIL.COM 00201001108688 MINIA UNIVERSITY FACULTY OF PHARMACY
City Postal code Country Position/Affiliation
MINIA Egypt ASS PROFESSOR
Role Name Email Phone Street address
Scientific Enquiries KHALED ALY KHALEDAK17@YAHOO.COM 00201149108370 FACULTY OF PHARMACY
City Postal code Country Position/Affiliation
MINIA Egypt PROFESSOR OF PHARMACEUTICS
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study was conducted on thirty five patients with chronic wound. The study included 16 (45.7%) males and 19 (54.2%) females. Statistical Analysis Plan Two years The statistical analysis was performed using one-way analysis of variance (ANOVA)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://ees.elsevier.com/ijs/default.asp Yes . On day 14 of treatment period, simvastatin treated patients showed complete healing of wounds in eight patients (44.4%), while only four patients (23.4%) showed complete wound healing in phenytoin treated patients. At the end of the treatment period (Four weeks), complete healing was evident in 13 patients (72%) of simvastatin group and 9 patients (52.9%) in phenytoin group. Patient who showed partial healing of their wounds were 4 patients (22.2%) in the study group versus 5 patients (29.4%) in the phenytoin group (positive control). Patient who showed no improvement were 2 patients (11.7%) in the phenytoin group versus no patient in the study group. 14/11/2019 01/04/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://ees.elsevier.com/ijs/default.asp
Changes to trial information