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NCT03205436
Affinity Prospective Diabetic Foot Trial Crossover Group
NA trial testing Affinity human amniotic membrane in Diabetic Foot Ulcer in 20 participants. Completed in 15 August 2019.
15 June 2019
Quick facts
| Lead sponsor | Organogenesis |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 May 2017 |
| Primary completion | 15 June 2019 |
| Estimated completion | 15 August 2019 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Affinity human amniotic membrane
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
Sponsor
Organogenesis — full company profile →
Who can join
18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03205436
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Foot Ulcer
Currently open trials in the same condition.
- NCT07161830 — Evaluating the Efficacy of OCM™ (Omeza® Complete Matrix) in the Treatment of Diabetic Foot Ulcers · NA · recruiting
- NCT07396376 — Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers · Phase 1, PHASE2 · recruiting
- NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers · NA · recruiting
Other Organogenesis trials
Trials by the same sponsor.
- NCT06618612 — A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguan · NA · recruiting
- NCT06000410 — A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee · Phase 3 · completed
- NCT04636229 — Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee · Phase 3 · completed
- NCT03502824 — PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers. · NA · terminated
- NCT03286452 — The RESPOND Registry · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03205436 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Organogenesis
- Last refreshed: 19 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03205436.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing