Affinity Prospective Diabetic Foot Trial Crossover Group
A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers: Crossover Group From Standard of Care
1 other identifier
interventional
20
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2019
CompletedFebruary 19, 2020
February 1, 2020
2.1 years
June 28, 2017
February 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to initial closure of diabetic foot ulcer
12 weeks
Secondary Outcomes (3)
Proportion of healed wounds
12 weeks
Mean wastage of graft
12 weeks
Mean cost to heal
12 weeks
Study Arms (1)
Graft
EXPERIMENTALAffinity human amniotic membrane
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organogenesislead
- SerenaGroup, Inc.collaborator
Study Sites (6)
GF Professional Research
Miami Lakes, Florida, 33016, United States
Barry University Clinical Research
North Miami Beach, Florida, 33169, United States
The Foot and Ankle Wellness Center
Ford City, Pennsylvania, 16226, United States
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201, United States
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222, United States
Martin Foot and Ankle
York, Pennsylvania, 17402, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 2, 2017
Study Start
May 1, 2017
Primary Completion
June 15, 2019
Study Completion
August 15, 2019
Last Updated
February 19, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share