Wound HealingPhase 1NCT02241811
Wound Treatment With 3% Sodium Pentaborate Pentahydrate
A Phase 1 study testing 3% Sodium Pentaborate Pentahydrate in people with Wound Healing, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Healing
- What is being tested?
- 3% Sodium Pentaborate Pentahydrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2014to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic Foot wounds
Who cannot join
- Child
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakif University
Istanbul, 34093
Erhan Aysan, MD Prof., +905322034879, erhanaysan@hotmail.com
Erhan Aysan, MD Prof.
About this study
Official title: 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.
Read the 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
- Being tested
- 3% Sodium Pentaborate Pentahydrate, Placebo
- Keywords
- Diabetic, Foot, Wound, Sodium pentaborate pentahydrate, Hydrogel
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Sodium Pentaborate PentahydrateDrug
Also called 3% Sodium Pentaborate Pentahydrate group, Control Group
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.
PlaceboDrug
Hydrogel without 3% Sodium Pentaborate Pentahydrate
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: 3% Sodium Pentaborate Pentahydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing, Complication
observation of wound healing and complications
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, Erhan Aysan, SB Istanbul Education and Research Hospital
- Investigators
- Erhan Aysan, MD Prof., Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241811
- Sponsor's protocol ID
- Boron wound
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Diabetic Foot Wound Treatment With Hydrogel Including 3% Sodium Pentaborate Pentahydrate
- ClinicalTrials.gov ID
- NCT02241811
- Acronym / sponsor ID
- Boron wound
- Conditions
- Wound Healing
- Keywords
- Diabetic, Foot, Wound, Sodium pentaborate pentahydrate, Hydrogel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- Sep 2014
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboAfter 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. |
| 3% Sodium Pentaborate Pentahydrate | Experimental | Drug: 3% Sodium Pentaborate PentahydrateFor 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic Foot wounds
Key exclusion criteria (1 listed)
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% Sodium Pentaborate PentahydrateAlso: 3% Sodium Pentaborate Pentahydrate group, Control GroupFor 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 |
| PlaceboHydrogel without 3% Sodium Pentaborate Pentahydrate | Drug | Control |
Primary outcome
Wound healing, Complication
Time frame: 2 months
observation of wound healing and complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erhan Aysan, MD Prof. principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 3% Sodium Pentaborate Pentahydrate in people with Wound Healing, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erhan Aysan, MD Prof. (+905322034879, erhanaysan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing, Complication (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.