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| Name | Class |
|---|---|
| Bezmialem Vakif University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% Sodium Pentaborate Pentahydrate | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing, Complication | observation of wound healing and complications | 2 months |
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Inclusion Criteria:
Diabetic Foot wounds
Exclusion Criteria:
Child
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erhan Aysan, MD Prof. | Contact | +905322034879 | erhanaysan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Erhan Aysan, MD Prof. | Bezmialem Vakif University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bezmialem Vakif University | Recruiting | Istanbul | 34093 | Turkey (Türkiye) |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 21, 2021 | |
| Reset | Jan 31, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 21, 2021 | Jan 31, 2022 |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Placebo | Drug | Hydrogel without 3% Sodium Pentaborate Pentahydrate |
|
| D008722 | Methods |