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Clinical trials
catalyst calendar across sponsors →Studies where ORGO is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
24 interventional · 3 observational · 5 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Clinical Trial Evaluating NuShield® Plus Standard of Care (SOC) Versus Standard of Care (SOC) Alone in the Management of Non-Healing Venous Leg Ulcers (VLUs)NCT07510412The proportion of subjects that obtain complete closureRandomized · Single-masked · Treatment | Not applicable | Recruiting | Other: NuShield® | Venous Leg Ulcers | 200 | Apr 2029 | ≤ 985 d | 2026-04-03 |
| A Study to Evaluate the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot UlcersNCT06618612Determine the efficacy of multiple Polyhexamethylene Biguanide Antimicrobial (PCMPs) plus SOC versus SOC alone in achieving complete closureRandomized · Open-label · Treatment | Not applicable | Recruiting | Other: Standard of Care · Device: PuraPly AM, PuraPly XT | Diabetic Foot Ulcer | 170 | 2026-08-19 | today | 2025-04-04 |
| A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneeNCT06000410The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patientsRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: Amniotic Suspension Allograft · Drug: Placebo | Knee Osteoarthritis | 594 | 2025-08-15actual | — | 2026-04-21 |
| Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the KneeNCT04636229The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patientsRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Biological: Amniotic Suspension Allograft · Drug: Placebo | Knee Osteoarthritis | 516 | 2023-07-30actual | — | 2025-10-16 |
| Clinical Study Of Affinity Versus SOC In The Management Of VLUsNCT04901013Length of time that a wound achieves complete wound closure (CWC)Randomized · Open-label · Treatment | Not applicable | Unknown status | Other: Affinity | Venous Leg Ulcer | 200 | Mar 2023 | — | 2021-09-08 |
| Study of Nucel for One and Two Level Lumbar Interbody FusionNCT02808234Fusion rate using non-contrast CT of the lumbar spineOpen-label · Treatment | Not applicable | Unknown status | Procedure: One or two level lumbar interbody fusion surgery · Other: Nucel | Degenerative Disc Disease, Spondylolisthesis, Spondylosis | 200 | Dec 2022 | — | 2021-05-26 |
| Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot UlcersNCT03855514Length of time that a wound achieves complete wound closure (CWC)Randomized · Open-label · Treatment | Not applicable | Unknown status | Other: NuShield | Diabetic Foot Ulcer | 200 | Nov 2021 | — | 2021-05-26 |
| PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.NCT03502824Reduction in size of ulcer area between groupsRandomized · Open-label · Other | Not applicable | Terminatedsponsor's stated reason: slow enrollment | Device: PuraPly® Antimicrobial Wound Matrix · Other: SOC for Pressure Ulcers | Chronic Pressure Ulcers | 40 | 2021-09-15actual | — | 2021-09-22 |
| Affinity Prospective Diabetic Foot Trial Crossover GroupNCT03205436Time to initial closure of diabetic foot ulcerOpen-label · Treatment | Not applicable | Completed | Other: Affinity human amniotic membrane | Diabetic Foot Ulcer | 20 | 2019-06-15actual | — | 2020-02-19 |
| Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot UlcersNCT02880592Time to initial closure of diabetic foot ulcerRandomized · Open-label · Treatment | Not applicable | Completed | Other: Affinity Allograft, Standard of care | Diabetic Foot Ulcers | 89 | 2019-04-01actual | — | 2020-02-19 |
| The RESPOND RegistryNCT03286452observationalReduction in size of wound area | — | Completed | Device: PuraPly™ Antimicrobial Wound Matrix | Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wounds, Trauma Wounds, Draining Wounds, Chronic Vascular Ulcer | 310 | 2018-07-15actual | — | 2019-02-27 |
| PuraPly™ Antimicrobial Wound Matrix and Wound ManagementNCT03070938observationalImprovement in wound bed condition | — | Completed | Device: PuraPly™ Antimicrobial Wound Matrix | Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wound, Trauma Wound | 100 | Sep 2017actual | — | 2017-11-06 |
| Prospective PuraPly™ AM Case Series StudyNCT03070925observationalImprovement in wound bed condition | — | Completed | Device: PuraPly™ Antimicrobial Wound Matrix | Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds, Trauma Wounds | 43 | Apr 2017actual | — | 2017-08-31 |
| Safety Study of Gintuit™ in Subjects Requiring Socket GraftingNCT01929954Number of participants with adverse eventsRandomized · Open-label · Treatment | Phase 1/2 | Terminatedsponsor's stated reason: Changes in corporate business environment | Biological: Gintuit · Device: Bio-Gide | Edentulous Alveolar Ridge | 5 | Mar 2015actual | — | 2015-09-24 |
| A Study Of Pain And Quality Of Life Outcomes In Subjects With a Single Painful Venous Leg Ulcer Treated With Apligraf®NCT02011724Percent reduction in maximum VLU-related pain at Week 5Open-label · Supportive care | Phase 4 | Unknown status | Device: Apligraf | Venous Leg Ulcers | 100 | Jan 2014 | — | 2013-12-13 |
| A Post Marketing Study of Apligraf in Non-healing Wounds of Subjects With Venous Leg UlcersNCT01327937Determine changes in gene expression in subjects receiving Apligraf (includes Apligraf & Control NPTH) compared to 1 week post treatmentRandomized · Single-masked · Treatment | Phase 4 | Completed | Device: Apligraf · Other: Standard of Care Dressing Group | Venous Ulcer | 30 | Nov 2013actual | — | 2015-09-24 |
| Safety Study of VCT-01™ in Split-Thickness Skin Graft Donor Site WoundsNCT01292122Number of participants with Adverse Events and changes from Baseline Immunology at 1, 3, 6 and 12 MonthsRandomized · Open-label · Treatment | Not applicable | Terminated | Device: VCT-01 | Wounds | 3 | Sep 2012actual | — | 2012-12-20 |
| Pivotal Trial of Dermagraft(R) to Treat Venous Leg UlcersNCT00909870results2013-02-04Complete Healing of the Study Ulcer by Week 16.Randomized · Open-label · Treatment | Phase 3 | Completed | Device: Dermagraft(R), Profore | Venous Leg Ulcer | 537 | May 2011actual | — | 2018-06-18 |
| A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root CoverageNCT00679081results2011-11-21Overall Rate of Adverse Events (AEs)Randomized · Open-label · Treatment | Phase 1/2 | Terminated | Device: CelTx · Other: Autologous sub-epithelial connective tissue graft | Gingival Recession | 15 | Sep 2010actual | — | 2012-01-11 |
| A Pilot Study of Apligraf for the Treatment and Prevention of Recurrence of Excised KeloidsNCT00587587results2011-08-19The Primary Purpose of This Study Will be to Gain Preliminary Safety Experience With Apligraf in the Keloid Indication. The Number of Participants Experiencing AEs is Presented.Randomized · Open-label · Treatment | Phase 1/2 | Completed | Device: Apligraf · Other: Standard dressing regimen | Keloid | 30 | Mar 2010actual | — | 2011-08-19 |
| A Post-Marketing Clinical Study of Apligraf for Venous Leg UlcersNCT00648674To use the novel technology of microarrays to identify and characterize the molecular mechanisms through which Apligraf promotes healing of venous leg ulcers.Open-label · Treatment | Phase 4 | Withdrawn | Device: Apligraf | Varicose Ulcer | 0 | Mar 2010 | — | 2015-08-19 |
| Safety and Efficacy of Apligraf in Nonhealing Wounds of Subjects With Junctional or Dystrophic Epidermolysis Bullosa (EB)NCT00587223results2010-06-22Proportion of Wounds First Achieving 100% Epithelialization of Tissue With the Absence of Drainage (i.e. Complete Wound Closure) Through Study Week 12Randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Insufficient patient enrollment | Device: Apligraf · Other: Standard dressing regimen | Epidermolysis Bullosa, Junctional, Epidermolysis Bullosa Dystrophica | 1 | Dec 2008actual | — | 2010-06-29 |
| Safety and Efficacy of Gintuit(TM)for Oral Soft Tissue RegenerationNCT00587834results2012-11-08Percentage of Subjects With at Least 2 mm Keratinized Tissue (KT) at 6 Months at the Gintuit Treated Site.Randomized · Open-label · Treatment | Phase 3 | Completed | Device: Gintuit · Other: Autologous palatal tissue | Gingival Recession | 96 | Dec 2008actual | — | 2012-11-08 |
| A Pilot Clinical Trial of Gintuit (TM)in Establishing a Functional Zone of Attached GingivaNCT01547962Amount of attached gingivaRandomized · Open-label · Treatment | Not applicable | Completed | Device: Gintuit · Other: autologous Free Gingival Graft (FGG) | Gingival Recession | 25 | May 2006actual | — | 2012-04-09 |
| Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot UlcersNCT01181453Complete wound closureRandomized · Single-masked · Treatment | Phase 3 | Completed | Device: Dermagraft · Other: Comparator | Diabetic Foot Ulcer | 314 | Mar 2000actual | — | 2018-05-21 |
| Dermagraft(R) for the Treatment of Patients With Diabetic Foot UlcersNCT01181440Proportion of patients with complete wound closureRandomized · Single-masked · Treatment | Phase 3 | Completed | Device: Dermagraft(R) · Other: Conventional care | Diabetic Foot Ulcer | 281 | Jan 1997actual | — | 2018-05-21 |
| Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot UlcersNCT00512538Time to complete wound healing (full epithelialization with no drainage)Randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Interruption of business relations between Study Sponsor and Device Manufacturer | Device: Bi-layered cell therapy (Apligraf) | Diabetic Foot | 82 | — | — | 2007-08-07 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19