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This is an IRB-approved multicenter study.This non-inferiority study aims to evaluate differential healing rates between Lavior Diabetic Wound Gel and other Hydrogels. Study therapy will be started in the outpatient setting and followed accordingly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRIAL INTERVENTION | Active Comparator | Trial intervention is wound treatment with Lavior Diabetic Wound Gel. |
|
| CONTROL THERAPY | Active Comparator | Control therapy is defined as Smith & Nephew Solosite Gel Hydrogel Wound Dressing, according to actual guidelines or local clinical standards. Standard therapy is defined as the currently accepted and widely used treatment for the respective wound type, based on the results of past research. Therapy options for standard wound care are treatments that experts agree to be appropriate, accepted, and widely used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavior Diabetic Wound Gel | Drug | Daily application of hydrogel treatment for 60 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60. The primary endpoint of this trial is defined as time (number of days) to achieve complete wound closure in study participants where closure was observed on or before Day 60. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of wound closures within 60 days | The incidence of wound closure achieved within each treatment arm will be evaluated after a maximum study observation/treatment period of 60 days | 60 days |
| Recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sung-Ho Steve Bae, DPM | Baefoot Podiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baefoot Podiatry | Miami | Florida | 33138 | United States |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Multicenter, randomized controlled, double-blinded clinical Non-inferiority trial
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The Study Participant, The Care Provider, and the Investigator are all blinded from the treatments.
| Smith & Nephew Solosite Gel Hydrogel Wound Dressing |
| Drug |
Daily application of hydrogel treatment for 60 days. |
|
Recurrence of wound opening after initial closure and confirmed wound closure will be assessed and compared between the treatment groups.
| 60 days |
| Change in wound depth over time (cm) | Change in wound depth (cm) over time will be evaluated by measurement of wound depth (cm) over time | 60 Days |
| Change in wound surface area over time (cm) | Change in wound surface area (cm) over time will be evaluated by measurement of wound surface area (cm) over time. | 60 Days |
| Change of wound size over time (cm) | Change of Necrotic wound bed surface area (cm) will be evaluated by measurement of necrotic area of wound (cm) over time. Photographic details of wound will be captured at each visit with standardized disposable ruler (cm). | 60 days |
| Change in Pain Scores over time (60 days) | Change in pain scores will be recorded over time (60 days) through the use of a patient reported 0 -10 scale. | 60 days |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |