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NCT01433159 · ClinicalTrials.gov registry record · Phase 2

Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury

A Phase 2 study, sponsored by Healthpoint.

Terminated
Registry status
Phase 2
Development phase
19
Enrollment target

NCT01433159: Clinical Trial Phase 2 study, sponsored by Healthpoint.

NCT01433159 is a Phase 2 study that was terminated before completion, run by Healthpoint. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01433159, a Phase 2 study, was terminated before completion, sponsored by Healthpoint.

TERMINATED
Registry status
Phase 2
Development phase
19 participants
Enrollment target

Study Summary

The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury, measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.

Primary Outcome

Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (\>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores. Cumulative Scores = 0 (Best

Interventions

  • DRUG Standard Care
  • DRUG HP011-101 (Xenaderm Ointment)

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2011-09
Est. Completion 2013-01
Phase Phase 2
Healthpoint

25 total trials

Why NCT01433159 stopped before completion

NCT01433159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard Care is the first listed.

NCT01433159 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01433159 about?

NCT01433159 is a clinical study titled "Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury". The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury, measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.

What is the current status of trial NCT01433159?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2011-09. Estimated completion is 2013-01.

What interventions are being tested in trial NCT01433159?

The interventions under investigation include: Standard Care (DRUG), HP011-101 (Xenaderm Ointment) (DRUG).

Who is sponsoring clinical trial NCT01433159?

This trial is sponsored by Healthpoint, which has 25 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01433159's enrollment target sits among peer trials

19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01433159, the US trial registry maintained by the National Library of Medicine. NCT01433159 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.