An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2018 |
| Start Date: | November 9, 2018 |
| End Date: | December 1, 2019 |
| Contact: | Stephanie Martynenko |
| Email: | smartynenko@medline.com |
| Phone: | 224-216-3822 |
A Case Series Evaluating a Fibrillar Collagen Powder Dressing to Treat Chronic, Stalled Lower-extremity Wounds
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.
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.
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
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