An observational study in Venous Leg Ulcer and Venous Stasis Ulcer, sponsored by Healthpoint. Completed at 30 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-02.
Sponsored by Healthpoint (part of Smith & Nephew, Inc.) · Observational
This is a 24-week observational follow safety study for Study 802-247-09-015.
The objective of this study is to examine the durability of previous target wound closures, identify new test article-related adverse events, record new target wound closures, and examine ongoing adverse events not resolved in subjects who participated in HP 802-247-09-015.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 206 is above the median of 131 across 47 observational studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Healthpoint is the lead sponsor of 34 studies on the registry; none are open to participants now.
First submitted before Healthpoint became part of Smith & Nephew, Inc..
Counted across the registry records on this site, refreshed daily.
Subjects who participated in Study No. 802-247-09-015 - "A Phase II Randomized, Double Blind, Placebo Controlled Dose Finding Study Investigating the Efficacy of HP802-247 in Venous Leg Ulcers" and agreed to continue with the follow-up study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment received in Study 802-247-09-015 was HP802
Biological: No HP802 Treatment
Treatment received in Study 802-247-09-015 was HP802 Vehicle
Other: No HP802 Vehicle Treatment
The Number of Participants With Closed Target Ulcers at Each Visit
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
Time frame: Over the 24-week study period, at each of the bi-monthly visits
Number of Subjects With Target Wound Closed for the First Time During the Study Period.
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
Time frame: Over the 24-week study period, at each of the bi-monthly visits
Eligible subjects were those who completed study 802-247-09-015. Of the 228 subjects who completed 802-247-09-015, 206 consented to enter this safety follow up study, between June 1, 2009 and October, 20, 2011.
| Milestone | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Started | 38 | 41 | 41 | 42 | 44 |
| Completed | 35 | 37 | 38 | 35 | 38 |
| Not completed | 3 | 4 | 3 | 7 | 6 |
| Withdrew: Lost to follow-up | 0 | 2 | 1 | 4 | 4 |
| Withdrew: Withdrawal by subject | 2 | 2 | 1 | 1 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 | 1 |
| Withdrew: Death | 1 | 0 | 0 | 1 | 0 |
At each visit the status of closed target ulcers was evaluated as remained closed or re-opened.
| participants | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Enrollment | 27 | 21 | 25 | 23 | 18 |
| Month 2 (Visit 1) | 22 | 19 | 24 | 20 | 17 |
| Month 4 (Visit 2) | 25 | 19 | 22 | 21 | 16 |
| Month 6 (Visit 3) | 25 | 19 | 21 | 20 | 15 |
At each visit the status of open target ulcers was evaluated as "remained open" or "closed".
| participants | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Month 2 (Visit 1) | 3 | 1 | 4 | 2 | 4 |
| Month 4 (Visit 2) | 5 | 3 | 4 | 5 | 8 |
| Month 6 (Visit 3) | 4 | 4 | 7 | 6 | 7 |
Collected over The duration of the 24-week study period. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LD-Q14D | — | 3/38 (7.9%) | 10/38 (26.3%) |
| LD-Q7D | — | 0/41 (0%) | 6/41 (14.6%) |
| HD-Q14D | — | 4/41 (9.8%) | 5/41 (12.2%) |
| HD-Q7D | — | 5/42 (11.9%) | 11/42 (26.2%) |
| HP802-247 Vehicle | — | 4/44 (9.1%) | 14/44 (31.8%) |
| Event | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Cardiac failure congestiveCardiac disorders | 0/38 | 0/41 | 0/41 | 2/42 | 0/44 |
| Supraventricular tachycardiaCardiac disorders | 1/38 | 0/41 | 0/41 | 0/42 | 2/44 |
| ArrhythmiaCardiac disorders | 1/38 | 0/41 | 0/41 | 0/42 | 0/44 |
| CellulitisInfections and infestations | 1/38 | 0/41 | 1/41 | 0/42 | 0/44 |
| Deep vein thrombosisVascular disorders | 1/38 | 0/41 | 0/41 | 0/42 | 0/44 |
| PneumoniaInfections and infestations | 0/38 | 0/41 | 1/41 | 0/42 | 1/44 |
| Femoral neck fractureInjury, poisoning and procedural complications | 0/38 | 0/41 | 1/41 | 0/42 | 1/44 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 0/38 | 0/41 | 1/41 | 0/42 | 0/44 |
| Malignant soft tissue neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/38 | 0/41 | 1/41 | 0/42 | 0/44 |
| Acute coronary syndromeCardiac disorders | 0/38 | 0/41 | 0/41 | 1/42 | 0/44 |
| Event | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | HP802-247 Vehicle |
|---|---|---|---|---|---|
| Skin and subcutaneous tissue disordersSkin and subcutaneous tissue disorders | 4/38 | 3/41 | 2/41 | 4/42 | 9/44 |
| Infections and infestationsInfections and infestations | 5/38 | 2/41 | 1/41 | 5/42 | 7/44 |
| Skin ulcerSkin and subcutaneous tissue disorders | 4/38 | 2/41 | 0/41 | 3/42 | 6/44 |
| CellulitisInfections and infestations | 2/38 | 0/41 | 0/41 | 2/42 | 2/44 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 1/38 | 0/41 | 2/41 | 0/42 | 1/44 |
| Wound infectionInfections and infestations | 1/38 | 1/41 | 1/41 | 2/42 | 2/44 |
| Dry skinSkin and subcutaneous tissue disorders | 0/38 | 0/41 | 1/41 | 0/42 | 2/44 |
Subjects and PIs remained blinded as treatment in the 802-247-09-015 study. There were no restrictions as to treatment by the PIs during this study. Blinding was maintained in order to assess the final outcomes of this study in relation to the therapy received in the prior study
| Age, Customized(participants) | HP802-247 Vehicle | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | Total |
|---|---|---|---|---|---|---|
| 18-39 years | 1 | 4 | 3 | 3 | 4 | 15 |
| 40-49 years | 8 | 6 | 4 | 6 | 6 | 30 |
| 50-59 years | 11 | 7 | 10 | 8 | 6 | 42 |
| 60+ years | 24 | 21 | 24 | 24 | 26 | 119 |
| Sex: Female, Male(Participants) | HP802-247 Vehicle | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | Total |
|---|---|---|---|---|---|---|
| Female | 15 | 17 | 13 | 19 | 20 | 84 |
| Male | 29 | 21 | 28 | 22 | 22 | 122 |
| Ethnicity (NIH/OMB)(Participants) | HP802-247 Vehicle | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 9 | 11 | 10 | 6 | 12 | 48 |
| Not Hispanic or Latino | 35 | 27 | 31 | 35 | 30 | 158 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | HP802-247 Vehicle | LD-Q14D | LD-Q7D | HD-Q14D | HD-Q7D | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 8 | 9 | 11 | 8 | 45 |
| White | 31 | 29 | 28 | 29 | 30 | 147 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 1 | 4 | 1 | 3 | 12 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jun 2009, a primary completion of Oct 2011 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2016, 4 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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