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NCT03074981
Novel Methods for Management of Complicated Wounds
NA trial testing Combined TopClosure & Vcare Alpha in Complications Wounds in 50 participants. Status unknown.
30 June 2019
Quick facts
| Lead sponsor | Sheba Medical Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 1 June 2017 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 August 2019 |
Drugs / interventions tested
- Combined TopClosure & Vcare Alpha
Conditions studied
- Complications Wounds — all drugs for Complications Wounds →
Sponsor
Sheba Medical Center
Who can join
Adults 18 to 90, any sex, with Complications Wounds. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Difficult to heal wounds are a common and complex medical problem, causing suffer to the patients and challenging medical, social and economic burden on the health system. Based on data from the western world, it is estimated that in Israel, at any given time, 30 to 60 thousand patients with difficult to heal wounds. Among diabetics patients, it is estimated that 15% to 25% will develop a difficult to heal foot wounds during their live time. The medical definition of a difficult to heal wounds is: a wound showing no signs of recovery after 4-6 weeks of treatment. Most of these wounds are caused by anaerobic bacteria inventions. One of the methods for the treatment of difficult to heal wounds is - ROI-RNPT (Regulated Oxygen -Enriched \& Irrigation Negative Pressure -Assisted Wound Therapy). This method creates in the wound a negative pressure in the presence of oxygen and irrigation applied directly into the wound bed. As part of the wound closure process the investigators will use the "external tissue expansion". This method under clinical use is exercised by the - "Top Closure" "tension relief system" (TRS). In this study, the investigators intend to investigate whether ROI-NPT system combined with TopClosure, is effective for the treatment of difficult to heal wounds, compared with methods currently in use.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03074981
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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 NCT03074981 (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 Sheba Medical Center
- Last refreshed: 9 May 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/NCT03074981.
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