NCT02241811

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

January 15, 2019

Status Verified

September 1, 2018

Enrollment Period

7.3 years

First QC Date

September 13, 2014

Last Update Submit

January 14, 2019

Conditions

Wound Healing

Keywords

DiabeticFootWoundSodium pentaborate pentahydrateHydrogel

Outcome Measures

Primary Outcomes (1)

  • Wound healing, Complication

    observation of wound healing and complications

    2 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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

3% Sodium Pentaborate Pentahydrate

EXPERIMENTAL

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

Interventions

3% Sodium Pentaborate PentahydrateDRUG

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.

Also known as: 3% Sodium Pentaborate Pentahydrate group, Control Group
3% Sodium Pentaborate Pentahydrate
PlaceboDRUG

Hydrogel without 3% Sodium Pentaborate Pentahydrate

Control

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic Foot wounds

You may not qualify if:

  • Child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Erhan Aysan, MD Prof.

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erhan Aysan, MD Prof.

CONTACT

+905322034879erhanaysan@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Prof.

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 16, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2021

Study Completion

December 1, 2023

Last Updated

January 15, 2019

Record last verified: 2018-09

Locations

TU(1)