Affinity Prospective Diabetic Foot Trial Crossover Group

Completed · Not applicable

Conditions studied: Diabetic Foot Ulcer

In brief

This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met.

Key facts

Study ID

NCT03205436

Run by

Organogenesis

People needed

20

Starts

2017-05-01

Expected to finish

2019-08-15

Last updated by the study team

2020-02-19

Who can join

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

You may qualify if…

• A percentage area reduction of less than 40% after having received 6 weeks of treatment with SOC in the NT-DFU-01 trial.
• Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
• Subject has read and signed the IRB/IEC approved Informed Consent Form.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
• At least 18 years old.

You may not qualify if…

• Failure to complete 6 weeks of SOC in the original NT-DFU-01 study
• Any AE or SAE that occurred during the NT-DFU-01 study, which, in the opinion of the investigator would preclude the subject successfully having Affinity applied for up to 12 weeks.
• Subject is unlikely to complete a regimen of Affinity and SOC for up to 12 weeks due to personal reasons.
• Subject is pregnant or breast feeding.
• Osteomyelitis or bone infection of the affected foot as assessed by X-ray.

Where it is running

• GF Professional Research — Miami Lakes, Florida, United States
• Barry University Clinical Research — North Miami Beach, Florida, United States
• The Foot and Ankle Wellness Center — Ford City, Pennsylvania, United States
• Armstrong County Memorial Hospital — Kittanning, Pennsylvania, United States
• SerenaGroup Research Institute — Pittsburgh, Pennsylvania, United States
• Martin Foot and Ankle — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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