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A Dose Finding Study of Topically Applied I-020201 as an Adjunct to Good Standard-of-care in Patients With Chronic Diabetic Foot Ulcers

NCT00915486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 211

Last updated 2012-03-16

No results posted yet for this study

Summary

Although major improvements in the management and treatment of diabetic foot ulcers have been made, the clinical and financial burden of such long-term wounds is still high and is likely to increase as the general population ages. The large population affected by diabetic foot ulcers and the high rates of failure ending with amputation even with the best therapeutic regimens have resulted in the development of new therapies. I-020201 is a bioactive therapy intended for topical treatment of hard-to-heal diabetic foot ulcers, stimulating the granulation tissue formation. This study aims to evaluate the safety and efficacy of I-020201 in adjunct to good standard of care in patients with chronic diabetic foot ulcer.

Conditions

  • Diabetic Foot Ulcer

Interventions

PROCEDURE

Good Standard of Care (GSoC)

Procedural treatment twice per week

BIOLOGICAL

Vehicle

Topical fibrin as an adjunct to GSoC twice per week

BIOLOGICAL

I-020201

Topical treatment with 3 different concentrations as an adjunct to GSoC twice per week

Sponsors & Collaborators

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Virginia Jamieson, MD · Kuros Biosurgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Czechia
  • Germany
  • Hungary
  • Romania
  • Russia
  • Serbia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00915486 on ClinicalTrials.gov