A Phase 3 interventional study of Dermagraft(R) and Profore in Venous Leg Ulcer, sponsored by Organogenesis. Completed at 70 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-18.
Sponsored by Organogenesis · Phase 3, Interventional, and Treatment
This study randomly assigns patients with venous leg ulcers to receive standard therapy (compression) alone or compression plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 16-week treatment period is complete. Follow-up visits are conducted monthly for three months in order to assess patients for longer term safety.
378 studies on the registry are indexed under Varicose Ulcer; 80 are open to participants now.
This study's enrollment of 537 is above the median of 64 across 325 interventional studies indexed under Varicose Ulcer.
Browse Varicose Ulcer studies →Organogenesis is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
Device: Dermagraft(R)
Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
Device: Profore
Weekly application of Dermagraft(R) with Profore compression as a secondary layer, in combination with systematic surgical wound debridement.
Weekly application of Profore compression dressings, in combination with systematic surgical wound debridement.
Complete Healing of the Study Ulcer by Week 16.
Time frame: 16 weeks
Time-to-Complete Healing
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
Time frame: From Week 0 visit to date subject's completely healed ulcer is 1st recorded as healed. If subject's ulcer not healed at 16 weeks, the "time until CH" was censored at 112 days.
Complete Healing by Week 16: Ulcers <= 12 Months Duration
Time frame: 16 weeks
Screening commenced in May 2009 and ended in November 2010. Study sites included vascular surgery, dermatology, and podiatry clinics. A total of 913 potential subjects were screened across 58 study centers; 395 subjects were screen failures. A total of 537 subjects were enrolled across 49 study centers.
| Milestone | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Active Control (Standard-of-Care) |
|---|---|---|
| Started | 274 | 263 |
| Completed | 251 | 236 |
| Not completed | 23 | 27 |
| Withdrew: Adverse event | 13 | 7 |
| Withdrew: Protocol violation | 1 | 2 |
| Withdrew: Withdrawal by subject | 5 | 8 |
| Withdrew: Lost to follow-up | 3 | 3 |
| Withdrew: Physician decision | 0 | 2 |
| Withdrew: Other | 1 | 5 |
| participants | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) |
|---|---|---|
| Complete Healing of the Study Ulcer by Week 16. | 201 | 176 |
Kaplan-Meier survival analysis of the time to achieve median (50%) Complete Healing response in each treatment group.
| days | Investigational Treatment (Dermagraft Plus Standard-of=- Care) | Control (Standard-of-Care) |
|---|---|---|
| Time-to-Complete Healing | 58 (36 to 113) | 64 (36 to 113) |
| participants | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) |
|---|---|---|
| Complete Healing by Week 16: Ulcers <= 12 Months Duration | 158 | 132 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Investigational Treatment (Dermagraft Plus Standard-of-Care) | — | 28/274 (10.2%) | 168/274 (61.3%) |
| Control (Standard-of-Care) | — | 24/263 (9.1%) | 157/263 (59.7%) |
| Event | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) |
|---|---|---|
| Atrial FibrilationCardiac disorders | 0/274 | 3/263 |
| PneumoniaInfections and infestations | 2/274 | 3/263 |
| DeathGeneral disorders | 3/274 | 2/263 |
| Cardiac failure congestiveCardiac disorders | 0/274 | 2/263 |
| BronchitisInfections and infestations | 0/274 | 2/263 |
| Infected skin ulcerInfections and infestations | 2/274 | 2/263 |
| CellulitisInfections and infestations | 2/274 | 1/263 |
| Therapy regimen changedSurgical and medical procedures | 2/274 | 0/263 |
| Acute Myocardial InfarctionCardiac disorders | 0/274 | 1/263 |
| Angina UnstableCardiac disorders | 0/274 | 1/263 |
| Event | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) |
|---|---|---|
| Skin UlcerSkin and subcutaneous tissue disorders | 77/274 | 60/263 |
| Infected skin ulcerInfections and infestations | 22/274 | 25/263 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 17/274 | 25/263 |
| ExcoriationInjury, poisoning and procedural complications | 20/274 | 16/263 |
| NasopharyngitisInfections and infestations | 18/274 | 18/263 |
| HypertensionVascular disorders | 14/274 | 13/263 |
| Age, Continuous(Years) | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) | Total |
|---|---|---|---|
| Mean | 63.1 ± 13.04 | 63.2 ± 14.46 | 63.1 ± 13.74 |
| Sex: Female, Male(Participants) | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) | Total |
|---|---|---|---|
| Female | 158 | 146 | 304 |
| Male | 116 | 117 | 233 |
| Region of Enrollment(participants) | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) | Total |
|---|---|---|---|
| United States | 94 | 93 | 187 |
| Estonia | 10 | 9 | 19 |
| Poland | 81 | 74 | 155 |
| South Africa | 73 | 71 | 144 |
| Germany | 8 | 8 | 16 |
| United Kingdom | 6 | 7 | 13 |
| Sweden | 2 | 1 | 3 |
| Ulcer Size(centimeters-squared) | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) | Total |
|---|---|---|---|
| Median | 5.75 (1.5 to 19.3) | 5.90 (2.0 to 24.8) | 5.9 (1.5 to 24.8) |
| Ulcer Duration(days) | Investigational Treatment (Dermagraft Plus Standard-of-Care) | Control (Standard-of-Care) | Total |
|---|---|---|---|
| Median | 206 (1 to 18157) | 228 (23 to 3834) | 214 (1 to 18157) |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Organogenesis