Wound Treatment With 3% Sodium Pentaborate Pentahydrate

NCT ID: NCT02241811

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2023-12-31

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.

Conditions

Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Hydrogel without 3% Sodium Pentaborate Pentahydrate

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.

Group Type: EXPERIMENTAL

3% Sodium Pentaborate Pentahydrate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Placebo

Hydrogel without 3% Sodium Pentaborate Pentahydrate

Intervention Type: DRUG

Other Intervention Names

3% Sodium Pentaborate Pentahydrate group, Control Group

Eligibility Criteria

Inclusion Criteria

Diabetic Foot wounds

Exclusion Criteria

Child

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: collaborator

SB Istanbul Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erhan Aysan

MD Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erhan Aysan, MD Prof.

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Erhan Aysan, MD Prof.

Role: CONTACT

erhanaysan@hotmail.com

+905322034879

Facility Contacts

Erhan Aysan, MD Prof.

Role: primary

erhanaysan@hotmail.com

+905322034879

Other Identifiers

Boron wound

Identifier Type: -

Identifier Source: org_study_id