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Wound Treatment With 3% Sodium Pentaborate Pentahydrate

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02241811
Enrollment
20
Registered
2014-09-16
Start date
2014-09-30
Completion date
2023-12-31
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Healing

Keywords

Diabetic, Foot, Wound, Sodium pentaborate pentahydrate, Hydrogel

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.

Interventions

DRUG3% 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.

DRUGPlacebo

Hydrogel without 3% Sodium Pentaborate Pentahydrate

Sponsors

Bezmialem Vakif University
CollaboratorOTHER
SB Istanbul Education and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

Diabetic Foot wounds

Exclusion criteria

Child

Design outcomes

Primary

MeasureTime frameDescription
Wound healing, Complication2 monthsobservation of wound healing and complications

Countries

Turkey (Türkiye)

Contacts

Primary ContactErhan Aysan, MD Prof.
erhanaysan@hotmail.com+905322034879

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026