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More cost effective to source real world evidence data
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This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use.
Participation in the study is anticipated to be two weeks. The Avelleâ„¢ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avelle NPWT | Avelle Negative Pressure Wound Therapy administrated as indicated by IFU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelle NPWT | Device | Wound Management Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The reduction in wound size of the target wound between baseline and end of study | Area reduction will be assessed by measuring the wound area at Day 0, Day 6 (+/- 1 day), and Day 7 (+/- 1 day) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Healing Status | Assessment of wound progression between baseline and 14 day visit. Wounds will be assessed as healed or progressing towards healing by the investigator. | 14 days |
| Assessment of Skin |
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Inclusion Criteria:
Exclusion Criteria:
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The population will be recruited from the Investigators available population in the anticipated geographies of Colombia and Australia.
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| Name | Affiliation | Role |
|---|---|---|
| Jorge Ulloa | Contracted independent health professional | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Convatec Medical Care | Bogota | Cundinamarca | 11001000 | Colombia |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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Assessment of condition of surrounding skin and signs of infection around the wound using a standardized wound assessment tool (as captured within study database)
| 14 Days |
| Rate of Device Related Adverse Events | Assessment of rate of device related adverse events (ADE) associated with the dressings | 14 days |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |