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NCT05413746: REOXDFU
REOXCARE Dressing to Improve Healing in Diabetic Foot Ulcers (DFU)
NA trial testing Reoxcare antioxidant dressing in Diabetes Mellitus in 20 participants. Completed in 6 June 2020.
17 March 2020
Quick facts
| Lead sponsor | Histocell, S.L. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 5 February 2018 |
| Primary completion | 17 March 2020 |
| Estimated completion | 6 June 2020 |
| Sites | 2 locations across Spain |
Drugs / interventions tested
- Reoxcare antioxidant dressing
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
- Foot Ulcer — all drugs for Foot Ulcer →
- Neuroischemic Foot Ulcer — all drugs for Neuroischemic Foot Ulcer →
Sponsor
Histocell, S.L. — full company profile →
Who can join
18 and older, any sex, with Diabetes Mellitus or Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
It has been shown that diabetic patients present a significant increase in markers related to oxidative stress, which increases even more in those with diabetic foot ulcers and gradually depending on the severity of the injury and inversely to the mechanisms of physiological antioxidants of these patients. Therefore, these patients present a situation of oxidative stress (high lipid peroxidation), with an insufficient level of antioxidant enzymes to reverse this state, which leads to maintenance of the inflammatory situation and therefore the chronification of the ulcer. Investigators' aim in this study is to measure the benefits that the application of the product with antioxidant capacity REOXCARE can bring, together with the usual good clinical wound care guidelines and other essential therapeutic activities, such as pressure relief in the area of the ulcers.
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 NCT05413746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Histocell, S.L. trials
Trials by the same sponsor.
- NCT04289194 — Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome · Phase 1, PHASE2 · 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 NCT05413746 (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 Histocell, S.L.
- Last refreshed: 29 February 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/NCT05413746.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing