Trial Outcomes & Findings for An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds (NCT NCT03723603)
NCT ID: NCT03723603
Last Updated: 2020-03-18
Results Overview
TERMINATED
NA
8 participants
Baseline to 84 days
2020-03-18
Participant Flow
Participant milestones
| Measure |
Fibrillar Collagen Powder Dressing
Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline to 84 daysPopulation: Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 84 daysPopulation: Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. The Bates-Jensen Wound Assessment tool measures wound status. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 84 daysPopulation: Study terminated prematurely due to re-prioritization of study efforts. Data not assessed.
The pain score will be recorded with a verbal numeric pain rating scale from 0-10.
Outcome measures
Outcome data not reported
Adverse Events
Fibrillar Collagen Powder Dressing
Serious adverse events
| Measure |
Fibrillar Collagen Powder Dressing
n=3 participants at risk
Fibrillar collagen powder dressing: A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
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Cardiac disorders
Death
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33.3%
1/3 • Baseline to 12 weeks
Study terminated prematurely due to re-prioritization of study efforts. Serious Adverse Events were assessed and reported. Other non serious adverse events were not assessed.
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Infections and infestations
Infection
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33.3%
1/3 • Baseline to 12 weeks
Study terminated prematurely due to re-prioritization of study efforts. Serious Adverse Events were assessed and reported. Other non serious adverse events were not assessed.
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Injury, poisoning and procedural complications
Fall
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33.3%
1/3 • Baseline to 12 weeks
Study terminated prematurely due to re-prioritization of study efforts. Serious Adverse Events were assessed and reported. Other non serious adverse events were not assessed.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place