Wound Treatment With 3% Sodium Pentaborate Pentahydrate

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

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Healing
• Intervention / Treatment: Drug: Placebo; Drug: 3% Sodium Pentaborate Pentahydrate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Erhan Aysan, MD Prof.; Phone Number: +905322034879; Email: erhanaysan@hotmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Recruiting
    • Bezmialem Vakif University
    • Contact: Erhan Aysan, MD Prof.; Phone Number: +905322034879; Email: erhanaysan@hotmail.com
    • Principal Investigator: Erhan Aysan, MD Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Diabetic Foot wounds

Exclusion Criteria:

Child

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Drug: Placebo; Hydrogel without 3% Sodium Pentaborate Pentahydrate
Experimental: 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.	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.; Other Names: 3% Sodium Pentaborate Pentahydrate group, Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound healing, Complication	observation of wound healing and complications	2 months

Collaborators and Investigators

• Sponsor: SB Istanbul Education and Research Hospital
• Collaborators: Bezmialem Vakif University
• Investigators: Principal Investigator: Erhan Aysan, MD Prof., Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 13, 2014
• First Submitted That Met QC Criteria: September 13, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Diabetic; Wound; Foot; Hydrogel; Sodium pentaborate pentahydrate
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Boron wound