Wound Treatment With 3% Sodium Pentaborate Pentahydrate
Primary Purpose
Wound Healing
Status
Recruiting
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
3% Sodium Pentaborate Pentahydrate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Wound Healing focused on measuring Diabetic, Foot, Wound, Sodium pentaborate pentahydrate, Hydrogel
Eligibility Criteria
Inclusion Criteria:
Diabetic Foot wounds
Exclusion Criteria:
Child
Sites / Locations
- Bezmialem Vakif UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
3% Sodium Pentaborate Pentahydrate
Arm Description
After wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
Outcomes
Primary Outcome Measures
Wound healing, Complication
observation of wound healing and complications
Secondary Outcome Measures
Full Information
NCT ID
NCT02241811
First Posted
September 13, 2014
Last Updated
January 14, 2019
Sponsor
SB Istanbul Education and Research Hospital
Collaborators
Bezmialem Vakif University
1. Study Identification
Unique Protocol Identification Number
NCT02241811
Brief Title
Wound Treatment With 3% Sodium Pentaborate Pentahydrate
Official Title
Deep Diabetic Foot Wound Treatment With Hydrogel Including 3% Sodium Pentaborate Pentahydrate
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Recruiting
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SB Istanbul Education and Research Hospital
Collaborators
Bezmialem Vakif University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. This research is aim to observe the foot wound's recovery with 3% Sodium pentaborate pentahydrate hydrogel.
Detailed Description
Chronic foot wounds which is very difficult to treat are common especially in diabetic and peripheral arterial or venous insufficiency patients. For these reason we prepared a hydrogel formulations.
Gel preparation:
Hydrogel formulations were prepared by dispersing 1%(w/v) carbopol polymer (Carbopol Ultrez-21, Lubrizol, USA) in distilled water. Neutralization buffer (1.6g of 1M sodium hydroxide solution for 1L polymer-water suspension) was used for the gelation of the polymer. Sodium pentaborate pentahydrate (3% w/v), F68 (2% w/v) and F127 (2% w/v) were mixed into the blank hydrogel and stored at 4 °C until it completely dissolved (approximately 24 h). pH of the hydrogel formulation was set to 6.5-7.0 using 1M sodium hydroxide. The hydrogel without any active ingredient was used as negative control (vehicle).
For the first group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate, and for the control group after wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
Keywords
Diabetic, Foot, Wound, Sodium pentaborate pentahydrate, Hydrogel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
After wound dressing we applied hydrogel without any active ingredient everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
Arm Title
3% Sodium Pentaborate Pentahydrate
Arm Type
Experimental
Arm Description
For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
Intervention Type
Drug
Intervention Name(s)
3% Sodium Pentaborate Pentahydrate
Other Intervention Name(s)
3% Sodium Pentaborate Pentahydrate group, Control Group
Intervention Description
For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Hydrogel without 3% Sodium Pentaborate Pentahydrate
Primary Outcome Measure Information:
Title
Wound healing, Complication
Description
observation of wound healing and complications
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diabetic Foot wounds
Exclusion Criteria:
Child
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erhan Aysan, MD Prof.
Phone
+905322034879
Email
erhanaysan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erhan Aysan, MD Prof.
Organizational Affiliation
Bezmialem Vakif University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erhan Aysan, MD Prof.
Phone
+905322034879
Email
erhanaysan@hotmail.com
First Name & Middle Initial & Last Name & Degree
Erhan Aysan, MD Prof.
12. IPD Sharing Statement
Learn more about this trial
Wound Treatment With 3% Sodium Pentaborate Pentahydrate
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