Therapeutic potential of loaded doxycycline and Venlafaxine on nanofiber scaffolds for wound healing in diabetic foot
Design
Controlled clinical trial with 20 patients,With parallel groups, Randomized
Settings and conduct
This study was performed on the treatment of diabetic foot ulcer in endocrine and Metabolism Research Center of Isfahan in a clinical trial with control group.Patients in this group were randomly selected.The intervention group received medications dressing nanofiber scaffolds and a control group without dressing nanofiber scaffolds. their wounds were tracked at intervals.
Participants/Inclusion and exclusion criteria
All individuals between the ages of 45 and 65; with a diabetic foot ulcer that has not healed despite treatment within the past month (2-7 cm); Pain at rest and during walking were included in the study and pregnant or lactating patients; Septicemia, other systemic kidney diseases such as cancer, autoimmune diseases, blood disease, liver disease, etc.; Hospitalization due to severe illness within the past two months; Severe malnutrition; foot ulcers in non-diabetic patients for example syphilis, tuberculosis, or fungal infection; Any allergy to the compounds used in the scaffolding process; patients with osteomyelitis in the foot due to diabetes; Previous wounds at the same site of study were excluded.
Intervention groups
Intervention group: Patients in this group were treated with doxycycline and venlafaxine nanofiber (NATO stayed from Nano Novin Polymer Factory) scaffolds every other day after foot wash with serum, depending on the extent of the ulcer, they were treated for one week to 20 days.
Control group: Patients in this group were under normal treatment without scaffold dressing.
Main outcome variables
The size of the Ulcer, distance walked without pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160711028878N2
Registration date:2020-02-01, 1398/11/12
Registration timing:retrospective
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Maryam Allahverdi Khani
Name of organization / entity
Islamic Azad Univercity Najafabad Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 4229 1111
Email address
m.allahverdi@smd.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
2015-10-07, 1394/07/15
Actual recruitment end date
2018-05-10, 1397/02/20
Trial completion date
2018-10-27, 1397/08/05
Scientific title
Therapeutic potential of loaded doxycycline and Venlafaxine on nanofiber scaffolds for wound healing in diabetic foot
Public title
Effect of a mixture of doxycycline and venlafaxine on the healing of diabetic foot ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 and 65 years
Having diabetic foot ulcers that have not recovered despite a treatment during the past month (2-7 cm)
Having pain at rest and walking
Signature written consent
Exclusion criteria:
Pregnancy or breastfeeding
septicemia
Other systemic kidney diseases, such as cancer, autoimmune diseases, blood diseases, liver disease and ...
Hospitalization due to severe illness in the past two months
Severe malnutrition
The presence of ulcers at the feet of patients, except for diabetes, for example syphilis, tuberculosis, or fungal foot
Any allergy to the compounds used in the production of scaffolding
Having osteomyelitis in the diabetic foot
History of previous wound in the same place
Age
From 45 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
This study was a simple randomization study where 1 to 40 were written on a sheet and placed in a box in a manner that was unclear. One sheet was taken for each patient. Even numbers were assigned as the treatment group and odd numbers as the control group.
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, University Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2015-07-27, 1394/05/05
Ethics committee reference number
IR.MUI.REC.1395.4.079
Health conditions studied
1
Description of health condition studied
Treatment of diabetic foot ulcer
ICD-10 code
E11.5
ICD-10 code description
Type 2 diabetes mellitus with circulatory complications
Primary outcomes
1
Description
size of the Ulcer
Timepoint
Before starting the study, 2 weeks and in months of 1,2,12,18 after using drugs.
Method of measurement
biopsy
2
Description
distance walked without pain
Timepoint
Before starting the study, 2 weeks and in months of 1,2,12,18 after using drugs.
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Nanofibers containing doxycycline and venlafaxine were prepared from Nano Novin Polymer Factory (NATO MAND), then FTIR test was used to determine drug quantity and release rate. Their mechanical strength was then tested with a Tensile device. The morphology of the samples was analyzed by electron microscopy (TEM). The patients' foot ulcers were washed with serum and the nano-fiber scaffolds were placed on their wounds every other day, with treatment continued for one week to 20 days. Finally, the skin permeability of the drugs to nanofibers was tested on the hairless abdominal skin of the rat. The results were measured for a total duration of 12 weeks with a spectrophotometer.
Category
Treatment - Drugs
2
Description
Control group: This group had their normal treatment and scaffold dressing was not used to them.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology and Metabolism Research Center
Full name of responsible person
Rokhsareh Meamar
Street address
Endocrinology and Metabolism Research Center-Khorram St.-Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3668 0048
Fax
Email
Khorshidresearchersclub2018@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan Research Department of Medical Sciences
Full name of responsible person
Shaghayedgh Haghjoo Javanmard
Street address
Isfahan Research Department of Medical Sciences- Hezarjarib Street- Azadi Square- Isfahan
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 3060
Email
Shaghyeghhaghjoo@gmail.com
Web page address
https://emrc.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan Research Department 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
Esfahan University of Medical Sciences
Full name of responsible person
Rokhsareh Meamar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
University of Medical Sciences-University St.-Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3222 2127
Email
meamar@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rokhsareh Meamar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
University of Medical Sciences-University Street.-Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3222 2127
Email
meamar@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rokhsareh Meamar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmacology
Street address
University of Medical Sciences-University Street.-Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Phone
+98 31 3222 2127
Email
meamar@pharm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available