An Evaluation of a Collagen Dressing to Treat Chronic, Stalled Lower-extremity Wounds

Stopped early · Not applicable

Conditions studied: Wound

In brief

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.

Key facts

Study ID

NCT03723603

Run by

Medline Industries

People needed

8

Starts

2018-11-09

Expected to finish

2019-07-30

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Foot and Ankle Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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