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Evaluation of the effect of topical potassium permanganate 5% solution on foot ulcers in diabetic patients – a randomisad controled clinical trial

Protocol summary

Study aim
Despite the advantages of potassium permanganate, which include its low price, availability and ease of use for patients and its non-toxicity, due to the lack of scientific and research evidence, it still has no place in the treatment of diabetic foot ulcers. Therefore, the aim of this study is to investigate the effect of potassium permanganate in diabetic foot ulcers and its effect on local infection, wound size, wound healing and wound infection control
Design
A randomized clinical trial with a control group, with parallel groups, on 22 patients. The method of randomization will be used in a parallel way from the restricted randomization approach in the method of random allocation rule
Settings and conduct
This study will be conducted in the general surgery clinic and reconstructive surgery clinic of the hospital. Patients are divided into intervention and control groups, and the results of the intervention will be measured on days 0, 7, 14, and 21.
Participants/Inclusion and exclusion criteria
The inclusion criteria is outpatient referral, a diabetic foot ulcer with a Wagner score of 1 or 2, and the presence of a chronic neuropathic diabetic foot ulcer that has been present for at least 3 months. ischemia and progressive infection are exclusion criteria
Intervention groups
Patients are divided into two groups. The first group are candidates for standard diabetic foot ulcer treatment. which includes pressure removal from the diabetic foot ulcer, daily washing and daily examination of the ulcer. The second group are candidates to receive standard treatment plus local solution of potassium permanganate.
Main outcome variables
examination of local infection; degree and size of the wound; Examining the edges of the wound and granulation formation; Duration of complete wound healing and wound infection control on days 0, 7, 14 and 21

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221015056180N1
Registration date: 2022-11-02, 1401/08/11
Registration timing: prospective

Last update: 2022-11-02, 1401/08/11
Update count: 0
Registration date
2022-11-02, 1401/08/11
Registrant information
Name
Afrooz Haghdoost
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 8540
Email address
haghdoost@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-06, 1401/08/15
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of topical potassium permanganate 5% solution on foot ulcers in diabetic patients – a randomisad controled clinical trial
Public title
effect of potassium permanganate solution on diabetic foot
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatient referral Patients with type 2 diabetes Diabetic foot ulcer with Wagner score 1 or 2 Presence of chronic neuropathic and non-ischemic diabetic foot ulcer that has been present for at least 3 months Patients in the age range of 18 to 65 years
Exclusion criteria:
The presence of ischemia symptoms in the lower limbs and ankle-brachial index and toe-brachial index (ABI, TBI) less than 0.7 Advanced wound infection
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Type of randomization: in this research, in order to allocate patients to intervention and control groups, a resticted randomization approach will be used in a parallel way and random allocation rule. To generate random numbers, online randomization will be used at the following address http://www.graphpad.com/quickcalcs/index.cfm Allocation concealment method: Random allocation concealment method will be used for concealment. At the time of registration of eligible patients for the study, using identical sealed envelopes with random sequence, the patient will be a candidate to receive one of two types of treatment.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of research and technology of Guilan university of medical sciences, Siyadati St, Namju St
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2022-08-17, 1401/05/26
Ethics committee reference number
IR.GUMS.REC.1401.292

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
ICDE-10
ICD-10 code description
ﻣﺮﺑﻮط ﺑﻪ ﻋﻮارض ﻧﻮروﻟﻮژﻳﻚ و ﺳﺎﻳﺮ ﻋﻮارض دﻳﺎﺑﺖ

Primary outcomes

1

Description
Local infection of diabetic foot ulcer
Timepoint
Investigation of wound infection at the beginning of the study and then on days 7, 14 and 21
Method of measurement
Based on the examination and determining the Wagner score of diabetic foot ulcer

2

Description
Size of diabetic foot ulcer
Timepoint
Measurement of diabetic foot ulcer at the beginning of the study and then on days 7, 14 and 21
Method of measurement
With examination and caliper device

3

Description
Granulation tissue formation
Timepoint
Examination of granulation tissue formation at the beginning of the study and then on days 7, 14 and 21
Method of measurement
Based on examination of diabetic foot ulcer

Secondary outcomes

1

Description
The duration of complete healing of diabetic foot ulcer
Timepoint
At the beginning of the study and then on days 7, 14 and 21
Method of measurement
Based on the examination of the attending physician

Intervention groups

1

Description
Intervention group: Patients in the intervention group will wash the wound with soap and water every day and then use potassium permanganate 5% solution topically. This solution is bought by the researcher from the pharmacy. And every week, the patient will be given the necessary amount to consume for a week. To prepare a solution of potassium permanganate 5%, the pharmacist combines 5 grams of it with 100 cc of distilled water. (This will be done under standard conditions and by the pharmacist). Patients are instructed to apply the solution with cotton soaked in potassium permanganate to all parts of their diabetic foot ulcer, so that the whole ulcer is covered with the solution and the healthy parts of the skin are not covered with the solution and not to wash the wound with water after that.
Category
Treatment - Drugs

2

Description
Control group: The control group is a candidate to receive the standard treatment of diabetic foot ulcer. The standard treatment of diabetic foot ulcer is as follows: removal and transfer of pressure from the area of diabetic foot ulcer, daily washing of the ulcer with mild soap and water, checking the condition of the ulcer daily.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat hospital
Full name of responsible person
Dr Mohamad reza Mobayen
Street address
Khanali zade St, Namju St
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8633
Fax
+98 13 3336 8651
Email
velayathospital@gmail.com
Web page address
https://velayat.gums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Mohamad Reza Naghipoor
Street address
Deputy of research and technology, Siadati St, Namju St
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Web page address
https://research.gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Afrooz Haghdoost
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Burn and Regenerative Medicine Research center, Khanali Zade St, Namjoo St, Velayat hospital,
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
00931333368540
Email
haghdoost.afrooz@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Afrooz Haghdoost
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Burn and Regenerative Medicine Research center, Khanali Zade St, Namjoo St, Velayat hospital,
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8540
Email
haghdoost.afrooz@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Afrooz Haghdoost
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Burn and Regenerative Medicine Research center, Khanali Zade St, Namjoo St, Velayat hospital,
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3336 8540
Email
haghdoost.afrooz@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After deidentifying people, all the data obtained from the research, including the demographic information of the samples, clinical information and the results of the intervention can be shared.
When the data will become available and for how long
It is possible to access the results after six months from the publication of the results
To whom data/document is available
Researchers in academic centers and scientific research centers
Under which criteria data/document could be used
In order to data comparison in similar studies, the researchers of academic centers and scientific research centers have the possibility to receive data and re-analyze it if they comply with the principles of ethics in research.
From where data/document is obtainable
Burn and Regenerative Medicine Research Center, Guilan University of Medical Sciences, Rasht, Iran Address: Burn Research Center and Regenerative Medicine, Velayat Hospital (3rd floor), Namjo St., Rasht. Contact phone: +98-1333368540 Dr. Mohammad Reza Mobayen Email address: Mmobayen@gums.ac.ir
What processes are involved for a request to access data/document
Researchers should send a written request to receive data to the relevant email address. The review of the documents and the application is done within two to four weeks. Then, if the necessary conditions are met, the data will be provided to the researchers by the research center.
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