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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02241811
Other study ID # Boron wound
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 2014
Est. completion date December 2023

Study information

Verified date September 2018
Source SB Istanbul Education and Research Hospital
Contact Erhan Aysan, MD Prof.
Phone +905322034879
Email erhanaysan@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 2023
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

Diabetic Foot wounds

Exclusion Criteria:

Child

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
3% Sodium Pentaborate Pentahydrate
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.
Placebo
Hydrogel without 3% Sodium Pentaborate Pentahydrate

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
SB Istanbul Education and Research Hospital Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound healing, Complication observation of wound healing and complications 2 months
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