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NCT02119754
Open Label Trial of Topical PluroGel PN for the Treatment of Patients With Mildly Infected Diabetic Foot Ulcer CLINICAL PROTOCOL PGN-1300X
Phase 2 trial testing Plurogel PN in Diabetic Foot Ulcer in 15 participants. Completed in 1 September 2014.
1 September 2014
Quick facts
| Lead sponsor | PluroGen Therapeutics, Inc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 October 2013 |
| Primary completion | 1 September 2014 |
| Estimated completion | 1 September 2014 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- Plurogel PN — full drug profile →
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
- Infection — all drugs for Infection →
Sponsor
PluroGen Therapeutics, Inc — full company profile →
Who can join
18 and older, any sex, with Diabetic Foot Ulcer or Infection. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Clinical Response
Time frame: 14 days
Clinical Response is defined by the investigator's evaluation of the signs and symptoms of clinical infection.
Sponsor's own description
This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.
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 NCT02119754
- 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
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 NCT02119754 (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 PluroGen Therapeutics, Inc
- Last refreshed: 24 September 2014
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/NCT02119754.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing