A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Change in Wound Size Over Twelve Week Period
Study Overview
Brief Summary
Patients who meet the inclusion criteria will be provided with fibrillar collagen powder dressing. The powder dressing will be used in accordance with its label. After cleansing the wound by the clinical site staff, the powder is placed directly on the wound, and then the wound will be covered with an appropriate moisture retentive secondary dressing. Patients will visit the clinic twice a week to have the powder re-applied. Wound evaluations will take place once a week at the outpatient clinic, with the intervention lasting up to twelve weeks. Concurrent standard of care, such as compression for venous ulcers, will be provided.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has one of the following types of wounds below the knee: diabetic ulcers, pressure ulcers, venous ulcers, ulcers of mixed-vascular origin, traumatic wounds, or post-surgical wounds
- •Wound has been present for at least four weeks
- •Wound is free of necrotic tissue or debridement practices will take place prior to initial visit in order to remove necrotic tissue
- •Wound has failed at least one wound care treatment
- •Wound size is between 1 and 100 square centimeters
- •Patient has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
- •Wound is confirmed as being free of infection and absence of osteomyelitis
Exclusion Criteria
- •Pregnant, planning to become pregnant during the study timeframe, or breast feeding
- •Unable or unwilling to receive porcine collagen
- •Wound is infected or presence of osteomyelitis
- •Allergy or sensitivity to collagen
- •Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
Arms & Interventions
Fibrillar Collagen Powder Dressing
Intervention: Fibrillar collagen powder dressing (Device)
Outcomes
Primary Outcomes
Change in Wound Size Over Twelve Week Period
Time Frame: Baseline to 84 days
Secondary Outcomes
- Change in Bates-Jensen Wound Assessment Tool(Baseline to 84 days)
- Change in Reported Pain Level(Baseline to 84 days)