Wound Treatment With 3% Sodium Pentaborate Pentahydrate

Wound Healing Clinical Trial

Official title:

Deep Diabetic Foot Wound Treatment With Hydrogel Including 3% Sodium Pentaborate Pentahydrate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02241811
• Other study ID #: Boron wound
• Status: Recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

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