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Clinical Trials/CTRI/2023/10/058211
CTRI/2023/10/058211Active, not recruitingPhase 4

An open label, single-centric, post market clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer. - NI

Datt Mediproducts Pvt. Ltd0 sites22 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Enrollment
22
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Inclusion Criteria

  • •1. Adult male or female subjects within the age group of 18-70 years (Both included).
  • •2. Subject with HbA1c level below 7.5% (well-controlled diabetes mellitus may be permitted).
  • •3. Subject or their LAR, who is able to read and understand informed consent document, and ready to provide signed written Informed Consent document for data collection at pre-defined follow-up visits.
  • •4. Subject with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test (venous refilling <18 seconds) using Doppler ultrasound on the day of screening. 5. Subject with Ankle-Brachial Pressure Index (ABI) exam’s value of =0.80 in the affected limb.
  • •6. Subject’s ulcers that extend through the epidermis but not through tendon, or bone (Stage II or III (Asymptomatic) ulcers as per IAET definition).
  • •7. Subjects having active Venous leg ulcer of Grade C-5 and above.
  • •8. Venous leg ulcer (VLU) is present on the leg with full thickness but without exposure of deeper tissues (bone or tendon). 9. If Subject have more than one venous leg ulcer, then largest ulcer meeting criteria shall be consider for the study and only one wound will be considered.

Exclusion Criteria

  • •Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
  • •2. Ulcers of Class III: Symptoms with moderate exertion or, Class IV: Symptoms at rest.
  • •3. The ulcer to be treated requires operative debridement.
  • •4. Subject with active systemic infections
  • •5. Presence of an active systemic or local cancer or tumor of any kind (with the exception of non-melanoma skin cancer).
  • •6. Subjects with active osteomyelitis or connective tissue disease of the affected foot.
  • •7. Subjects found positive for HIV (The test reports valid for 6 months before screening).
  • •8. Concurrent participation in another clinical study 9. Female subject with positive Urine Pregnancy Test (UPT) on screening visit 1 or nursing woman.
  • •10. Subject with comorbidities which could interfere with clinical evaluations or interpretation of results.
  • •11. Subjects with known allergy to the constituents of investigational products/ device i.e. VELVERT.
  • •12. Subject on systemic corticosteroids (15 mg/day), or immunosuppressive therapy.
  • •13. Previous or current radiation therapy or likelihood to be received during the study duration.
  • •14. Poor adaptivity or seriously ill subjects who cannot finish the observation period.
  • •15. Any other condition which, according to the judgment of the investigator, could interfere in the study.
  • •16. Subjects with diabetic foot ulcer complications or with gangrene present on any part of the affected leg.
  • •17. Subjects with Ankle-brachial pressure index (ABPI) =0.8

Investigators

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