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A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers

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Trial Conditions
  • Venous Leg Ulcer
  • Venous Stasis Ulcers
What is the purpose of this trial?

This is a 16-week study for subjects with a venous leg ulcer between the knee and ankle. This research is being done to determine the effectiveness of two dosing frequencies and two different concentrations of HP802-247, together with standard care, compared to placebo, plus standard care.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

- Provide informed consent.

- Willing to comply with protocol instructions, including allowing all study
assessments.

- Have a venous leg ulcer (venous etiology)between the knee and ankle, at or above the
malleolus.

- Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular
or venous incompetence.

- Target ulcer duration greater than or equal to 6 weeks but less than or equal to 24
months.

Exclusion Criteria:

- Women who are pregnant or lactating

- Therapy with another investigational agent within thirty (30) days of Screening, or
during the study.

- A target ulcer of non-venous etiologies.

- Refusal of or inability to tolerate compression therapy.

- Therapy of the target ulcer with tissue-engineered cell-based skin equivalents within
30 days preceding the Screening Visit.

- Therapy of the target ulcer with topical growth factors within 1 week preceding the
Screening Visit.

Gender: Both
Steward Physician(s)
  • Herbert B Slade, MD
  • William Marston, MD
  • Robert Kirsner, MD
  • Robert J Snyder, MD
Facilities
  • New England Sinai Hospital - Completed
  • New England Sinai Hospital - Completed
Trial Interventions
Biological
  • HP802-247
Physician Researcher

Investigator Name:

  • Herbert B Slade, MD
  • William Marston, MD
  • Robert Kirsner, MD
  • Robert J Snyder, MD

Other Information

Sponsor: Healthpoint
Phase: Phase 2
Trial ID: NCT00852995
Volunteers:  Not Accepting Healthy Volunteers

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