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NCT02988063
Effect of PEM Treatment of Superficial Axial and Tributary Vein Reflux on Improvement of Wound Healing in VLUs
Phase 4 trial testing Polidocanol Endovenous Microfoam (PEM) in Leg Ulcer. Withdrawn.
12 September 2017
Quick facts
| Lead sponsor | OhioHealth |
|---|---|
| Phase | Phase 4 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 10 April 2017 |
| Primary completion | 12 September 2017 |
| Estimated completion | 12 September 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Polidocanol Endovenous Microfoam (PEM) — full drug profile →
Conditions studied
- Leg Ulcer — all drugs for Leg Ulcer →
- Veins, Varicose — all drugs for Veins, Varicose →
- Venous Ulcer — all drugs for Venous Ulcer →
- Reflux — all drugs for Reflux →
Sponsor
OhioHealth — full company profile →
Who can join
18 and older, any sex, with Leg Ulcer or Veins, Varicose. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the addition of polidocanol endovenous microfoam (PEM) to compression therapy to determine effectiveness in improving the healing of venous leg ulcers (VLUs) in adults with severe venous disease of the great saphenous vein (GSV). All participants will receive treatment with Varithena and compression therapy. The purpose of this study is to assess whether the use of PEM to correct superficial axial and varicose vein reflux is effective in improving healing of VLUs, over treatment with compression alone.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02988063
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Currently open trials in the same condition.
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Other OhioHealth trials
Trials by the same sponsor.
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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 NCT02988063 (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 OhioHealth
- Last refreshed: 15 September 2017
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/NCT02988063.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing