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NCT04922463
PLASOMA Efficacy & Technology Health (PETH) Study
NA trial testing PLASOMA in Venous Leg Ulcer in 46 participants. Terminated before completion.
20 April 2023
Quick facts
| Lead sponsor | Plasmacure |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 June 2021 |
| Primary completion | 20 April 2023 |
| Estimated completion | 20 April 2023 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- PLASOMA
Conditions studied
- Venous Leg Ulcer — all drugs for Venous Leg Ulcer →
Sponsor
Plasmacure
Who can join
18 and older, any sex, with Venous Leg Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is designed to examine beneficial effects of PLASOMA treatment compared to the standard of care on chronic venous leg ulcers (VLU) that match the size of the plasma area of the pad. The intention is that the data obtained with this study will be used to: 1. Demonstrate comparative performance of PLASOMA (for two treatment frequencies) 2. Provide evidence for health technology assessments (HTA) of PLASOMA
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Improved Wound Healing by Direct Cold Atmospheric Plasma Once or Twice a Week: A Randomized Controlled Trial on Chronic Venous Leg Ulcers.
Bakker O, Smits P, van Weersch C, Quaaden M, et al · · 2025 · cited 14× · PMID 38687339 · DOI 10.1089/wound.2023.0196 -
Reactive oxygen species in health and disease.
Ren Y, Li J, Dai X. · · 2026 · PMID 41824175 · DOI 10.1186/s43556-026-00419-2 -
Cold atmospheric plasma is a promising strategy for treating diabetic retinopathy.
Dai X, Cui W, Xi M. · · 2025 · PMID 41257900 · DOI 10.1186/s12967-025-06962-w
Verify or expand the search:
- PubMed search for NCT04922463
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PLASOMA
Trials testing the same drug.
- NCT04828304 — PLASOMA Ultimate Safety & Efficacy Study · NA · completed
Other recruiting trials for Venous Leg Ulcer
Currently open trials in the same condition.
- NCT07255937 — PMCF Study of Debridement Pad · NA · recruiting
- NCT07046767 — CAMP RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations · NA · recruiting
- NCT07211243 — Suprasorb®X+PHMB Pro vs Suprasorb®X+PHMB in Treatment of Infected Venous Leg Ulcers · NA · recruiting
- NCT07061613 — Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers · NA · recruiting
- NCT06544564 — Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population · NA · recruiting
Other Plasmacure trials
Trials by the same sponsor.
- NCT04828304 — PLASOMA Ultimate Safety & Efficacy Study · NA · 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 NCT04922463 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Plasmacure
- Last refreshed: 12 June 2024
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/NCT04922463.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing