A Phase 2 interventional study of HP802-247 and Placebo (Vehicle) in Venous Leg Ulcer and Venous Stasis Ulcers, sponsored by Healthpoint. Completed at 30 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-24.
Sponsored by Healthpoint (part of Smith & Nephew, Inc.) · Phase 2, Interventional, and Treatment
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.
369 studies on the registry are indexed under Varicose Ulcer; 77 are open to participants now.
This study's enrollment of 228 is above the median of 60 across 309 interventional 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..
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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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Low dose HP802-247, applied at each visit
Biological: HP802-247
Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
Biological: HP802-247
High dose HP802-247, applied at each visit
Biological: HP802-247
High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12
Biological: HP802-247
Placebo (Vehicle), applied at each visit
Biological: Placebo (Vehicle)
One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin.
Placebo (Vehicle) consisting of: Component 1 - acellular fibrinogen solution; Component 2 - acellular thrombin solution
The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Kaplan-Meier Probability of Non-Closure
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Time frame: 14 weeks - the final visit for one subject was delayed by two weeks
Percent of Change From Baseline in Target Wound Area at Each of the Twelve Double-blind Treatment Weeks.
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
Time frame: Weekly, over the 12 week treatment period, or until wound closure, which ever occurred first
Proportion of Subjects Achieving ≥ 50% Decrease in Target Wound Area From Baseline Through Week 13
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
Time frame: Over the 12 week treatment period or until the wound closed, which ever occurred first.
Percentage of Participants With Complete Wound Closure at Each Visit
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
Time frame: Weekly, over the 12 week treatment period
Target Ulcer Pain Was Measured Using a Visual Analog Scale [Range: 0mm - 100mm]. Subjects Marked Their Pain Level on a 100 mm Horizontal Line, With a Short Vertical Line Across the Scale, 0 Denoting no Pain and 100mm the Maximum Pain.
Target ulcer pain was measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
Time frame: Weekly, over the 12 week treatment period
Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline.
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
Time frame: 14 weeks - the final visit for one subject was delayed by two weeks
Subjects were screened at 34 sites in the US and one in Canada, between June 11, 2009 and May 5, 2011; sites included independent and hospital wound clinics and private practice sites.
| Milestone | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | E - HP802-247 Vehicle |
|---|---|---|---|---|---|
| Started | 46 | 43 | 44 | 45 | 50 |
| Completed | 38 | 42 | 39 | 40 | 46 |
| Not completed | 8 | 1 | 5 | 5 | 4 |
| Withdrew: Adverse event | 1 | 0 | 4 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 4 | 0 | 0 | 1 | 2 |
| Withdrew: Non-compliance | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Progressive disease | 1 | 0 | 0 | 2 | 1 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Moved out of area | 1 | 0 | 0 | 0 | 0 |
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, or until wound closure, whichever occurred first, using a laser-based wound imaging system in conjunction with software to measure area. An average of the 12 measurements were assessed.
| percent change | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | E - HP802-247 Vehicle |
|---|---|---|---|---|---|
| The Average Percent (%) Change From Baseline in the Target Wound Area in Each Treatment Group Over the Twelve-week Double-blind Treatment Period. | -77.11 ± 21.95 | -70.15 ± 21.66 | -68.14 ± 26.29 | -72.89 ± 27.27 | -60.38 ± 29.79 |
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
| Probability of Non-Closure | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| 01 week | 1 | 1 | 0.977 | 1 | 1 |
| 02 weeks | 1 | 0.978 | 0.977 | 1 | 0.978 |
| 03 weeks | 0.98 | 0.934 | 0.977 | 0.953 | 0.889 |
| 04 weeks | 0.918 | 0.934 | 0.907 | 0.907 | 0.867 |
| 05 weeks | 0.898 | 0.71 | 0.814 | 0.791 | 0.707 |
| 06 weeks | 0.834 | 0.596 | 0.814 | 0.791 | 0.661 |
| 07 weeks | 0.706 | 0.596 | 0.628 | 0.741 | 0.591 |
| 08 weeks | 0.663 | 0.431 | 0.581 | 0.537 | 0.543 |
| 09 weeks | 0.534 | 0.359 | 0.558 | 0.537 | 0.445 |
| 10 weeks | 0.512 | 0.332 | 0.558 | 0.537 | 0.418 |
| 11 weeks | 0.512 | 0.332 | 0.393 | 0.46 | 0.418 |
| 12 weeks | 0.512 | 0.276 | 0.393 | 0.379 | 0.288 |
| 13 weeks | 0.42 | 0.237 | 0.393 | 0.32 | 0.288 |
| 14 weeks | 0.42 | 0 | 0.393 | 0.32 | 0.288 |
For each treatment group the area of each subject's target ulcer was measured on a weekly basis, for up to 12 weeks, using a laser-based wound imaging system in conjunction with software to measure area.
| Percent change | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Tx Week 1 | -22.94 ± 3.97 | -38.88 ± 4.14 | -27.89 ± 4.27 | -25.88 ± 4.26 | -34.97 ± 4.17 |
| Tx Week 2 | -39.94 ± 4.9 | -58.95 ± 5.11 | -46.06 ± 5.26 | -43.69 ± 5.26 | -49.89 ± 5.14 |
| Tx Week 3 | -47.30 ± 5.0 | -65.56 ± 5.22 | -53.5 ± 5.37 | -55.2 ± 5.37 | -56.66 ± 5.25 |
| Tx Week 4 | -59.55 ± 5.28 | -73.46 ± 5.51 | -62.14 ± 5.68 | -60.68 ± 5.68 | -63.92 ± 5.55 |
| Tx Week 5 | -60.54 ± 5.29 | -79.98 ± 5.52 | -68.95 ± 5.68 | -61.87 ± 5.68 | -72.41 ± 5.55 |
| Tx Week 6 | -63.93 ± 4.63 | -81.05 ± 4.83 | -76.01 ± 4.98 | -74.7 ± 4.97 | -81.06 ± 4.86 |
| Tx Week 7 | -65.38 ± 4.64 | -87.22 ± 4.84 | -79.84 ± 4.99 | -77.63 ± 4.98 | -79.81 ± 4.87 |
| Tx Week 8 | -66.62 ± 5.04 | -83.00 ± 5.26 | -80.6 ± 5.42 | -81.58 ± 5.42 | -81.98 ± 5.3 |
| Tx Week 9 | -69.03 ± 4.78 | -83.28 ± 4.99 | -83.96 ± 5.14 | -84.28 ± 5.14 | -86.17 ± 5.02 |
| Tx Week 10 | -76.19 ± 3.39 | -89.65 ± 3.54 | -85.79 ± 3.65 | -86.98 ± 3.65 | -87.74 ± 3.56 |
| Tx Week 11 | -77.05 ± 3.57 | -89.26 ± 3.72 | -87.49 ± 3.84 | -83.37 ± 3.83 | -87.54 ± 3.75 |
| Tx Week 12 | -80.69 ± 3.54 | -90.67 ± 3.69 | -86.87 ± 3.8 | -84.52 ± 3.8 | -86.93 ± 3.72 |
The area of each subject's target wound was measured at each visit and the proportion of subjects with a decrease in area from baseline ≥ 50% was calculated for each treatment group.
| Responders | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Visit 2 | 8 | 17 | 5 | 6 | 13 |
| Visit 3 | 22 | 29 | 20 | 20 | 21 |
| Visit 4 | 28 | 34 | 23 | 24 | 31 |
| Visit 5 | 32 | 38 | 28 | 27 | 34 |
| Visit 6 | 36 | 40 | 32 | 31 | 36 |
| Visit 7 | 36 | 39 | 33 | 34 | 42 |
| Visit 8 | 36 | 43 | 38 | 35 | 41 |
| Visit 9 | 36 | 43 | 36 | 37 | 41 |
| Visit 10 | 41 | 40 | 38 | 37 | 40 |
| Visit 11 | 42 | 44 | 39 | 39 | 43 |
| Visit 12 | 40 | 42 | 42 | 37 | 41 |
| Visit 13 | 45 | 45 | 40 | 38 | 40 |
Treatment groups were compared for the proportion of wounds closed at each weekly visit. For subjects who dropped from the study, their remaining visit values were imputed using LOCF.
| percentage of participants | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Week 01 | 0 | 4.3 | 2.3 | 0 | 2.2 |
| Week 02 | 2.0 | 8.7 | 2.3 | 7.0 | 11.1 |
| Week 03 | 8.0 | 23.9 | 9.3 | 14.0 | 20.0 |
| Week 04 | 10.0 | 30.4 | 18.6 | 20.9 | 28.9 |
| Week 05 | 16.0 | 37.0 | 25.6 | 23.3 | 33.3 |
| Week 06 | 24.0 | 47.8 | 39.5 | 27.9 | 40.0 |
| Week 07 | 28.0 | 52.2 | 41.9 | 39.5 | 44.4 |
| Week 08 | 36.0 | 58.7 | 41.9 | 48.8 | 51.1 |
| Week 09 | 36.0 | 60.9 | 55.8 | 48.8 | 55.6 |
| Week 10 | 40.0 | 60.9 | 60.5 | 53.5 | 62.2 |
| Week 11 | 40.0 | 65.2 | 58.1 | 60.5 | 64.4 |
| Week 12 | 46.0 | 69.6 | 58.1 | 65.1 | 64.4 |
Target ulcer pain was measured using a Visual Analog Scale \[Range: 0mm - 100mm\]. Subjects marked their pain level on a 100 mm horizontal line, with a short vertical line across the scale, 0 denoting no pain and 100mm the maximum pain. Each weekly measurement is reported as the average of all subjects scores at each week per treatment group.
| units on a scale | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Baseline | 30.82 ± 31.22 | 21.11 ± 25.23 | 28.6 ± 21.77 | 29.84 ± 26.36 | 25.47 ± 27.7 |
| Week 03 | 21.68 ± 25.01 | 13.37 ± 18.61 | 16.87 ± 19.22 | 18.81 ± 22.15 | 14.42 ± 18.17 |
| Week 06 | 10.72 ± 18.22 | 10.35 ± 20.43 | 7.35 ± 13.36 | 12.25 ± 17.96 | 11.61 ± 19.03 |
| Week 09 | 9.3 ± 14.96 | 8.85 ± 18.53 | 4.53 ± 9.54 | 11.51 ± 18.29 | 7.01 ± 13.63 |
| Week 12 | 7.95 ± 13.34 | 6.83 ± 11.72 | 3.28 ± 6.83 | 13.22 ± 20.71 | 6.61 ± 13.43 |
This key secondary outcome was the days to wound closure based on a Kaplan-Meier survival analysis.
| Days to Closure | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Median Time to Achieve Complete Wound Closure, Based on Based on a Kaplan-Meier Survival Analysis, Over the 12-Week Treatment Period From Baseline. | 71 (57 to NA) | 50 (37 to 66) | 64 (43 to NA) | 57 (50 to 85) | 57 (43 to 71) |
Collected over The duration of the 12-week treatment period. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| E - HP802-247 Vehicle | — | 4/50 (8%) | 26/50 (52%) |
| B - Low Q14D | — | 4/46 (8.7%) | 15/46 (32.6%) |
| A - Low Q7D | — | 3/43 (7%) | 19/43 (44.2%) |
| D - High Q14D | — | 3/43 (7%) | 16/44 (36.4%) |
| C - High Q7D | — | 2/45 (4.4%) | 17/45 (37.8%) |
| Event | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Pneumonia pneumococcalInfections and infestations | 0/50 | 0/46 | 1/43 | 0/43 | 0/45 |
| Neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/50 | 0/46 | 0/43 | 1/43 | 0/45 |
| Alcohol withdrawal syndromePsychiatric disorders | 0/50 | 0/46 | 1/43 | 0/43 | 0/45 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 0/50 | 0/46 | 0/43 | 1/43 | 0/45 |
| Peripheral vascular disorderVascular disorders | 0/50 | 0/46 | 1/43 | 1/43 | 0/45 |
| Atrial fibrillationCardiac disorders | 0/50 | 0/46 | 0/43 | 0/43 | 1/45 |
| Cardiac failure congestiveCardiac disorders | 1/50 | 0/46 | 0/43 | 0/43 | 1/45 |
| Localised infectionInfections and infestations | 0/50 | 0/46 | 0/43 | 0/43 | 1/45 |
| Myocardial infarctionCardiac disorders | 0/50 | 1/46 | 0/43 | 0/43 | 0/45 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 0/50 | 1/46 | 0/43 | 0/43 | 0/45 |
| Event | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D |
|---|---|---|---|---|---|
| Skin and subcutaneousSkin and subcutaneous tissue disorders | 14/50 | 4/46 | 6/43 | 7/44 | 8/45 |
| Infections and infestationsInfections and infestations | 9/50 | 4/46 | 8/43 | 4/44 | 8/45 |
| Skin ulcerSkin and subcutaneous tissue disorders | 8/50 | 3/46 | 3/43 | 4/44 | 5/45 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 4/50 | 2/46 | 4/43 | 4/44 | 1/45 |
| Musculoskeletal and connective tissue disordersMusculoskeletal and connective tissue disorders | 0/50 | 3/46 | 1/43 | 1/44 | 3/45 |
| General disorders and administration site conditionsGeneral disorders | 3/50 | 2/46 | 0/43 | 2/44 | 0/45 |
| CellulitisInfections and infestations | 3/50 | 1/46 | 2/43 | 0/44 | 0/45 |
| ExcoriationInjury, poisoning and procedural complications | 2/50 | 0/46 | 2/43 | 0/44 | 0/45 |
| Psychiatric disordersNervous system disorders | 0/50 | 0/46 | 2/43 | 0/44 | 0/45 |
| Respiratory, thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 2/50 | 1/46 | 2/43 | 0/44 | 0/45 |
| Age, Continuous(years) | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | Total |
|---|---|---|---|---|---|---|
| Mean | 62.1 ± 14.1 | 61.7 ± 15.7 | 62.6 ± 15.4 | 59.8 ± 15.0 | 61.8 ± 16.1 | 61.6 ± 15.2 |
| Age, Customized(years) | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | Total |
|---|---|---|---|---|---|---|
| Female Age | 69.1 (49 to 90) | 61.8 (24 to 87) | 67.7 (33 to 89) | 65.1 (27 to 89) | 69.7 (39 to 94) | 66.5 (24 to 94) |
| Male Age | 58.4 (33 to 91) | 61.6 (24 to 88) | 60.1 (28 to 93) | 56.0 (22 to 75) | 58.2 (24 to 80) | 59.0 (22 to 93) |
| Sex: Female, Male(Participants) | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | Total |
|---|---|---|---|---|---|---|
| Female | 17 | 20 | 14 | 22 | 20 | 93 |
| Male | 33 | 26 | 29 | 22 | 25 | 135 |
| Ethnicity (NIH/OMB)(Participants) | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High Q7D | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 11 | 14 | 10 | 7 | 13 | 55 |
| Not Hispanic or Latino | 39 | 32 | 33 | 37 | 32 | 173 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | E - HP802-247 Vehicle | B - Low Q14D | A - Low Q7D | D - High Q14D | C - High 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 | 10 | 9 | 12 | 8 | 48 |
| White | 37 | 34 | 30 | 30 | 33 | 164 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 2 | 4 | 2 | 3 | 14 |
The record gives a start of Feb 2009, a primary completion of Apr 2011 and a completion of Jul 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2016, 4 years 11 months after primary completion. A results delay was requested in Sep 2013.
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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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Studies of the drug tested here: Topical Wound Spray HP802-247