Clinical trials: Skin Substitutes
Vascular Disease, Critical Lower Limb Ischemia
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.
- Trial name
- NCT00633659
- Testing
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Sangart
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Advanced Solid Tumors, Advanced Breast Cancer
Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors
Phase 1/2, open-label study of ETX-636 in participants with advanced solid tumors
- Trial name
- NCT06993844
- Testing
- ETX-636 dose escalation, ETX-636 dose escalation in combination with fulvestrant, ETX-636 dose expansion in combination with fulvestrant
- Where
- 15 sites in United States, China
- Volunteers
- 233 people
- Sponsor
- Ensem Therapeutics
Diabetic Foot Ulcer
Multi Center Site , Controlled Trial Comparing a Bioengineered Skin Substitute to a Human Skin Allograft
Despite the widespread use of advanced biologics for the treatment of diabetic foot ulcers, data comparing one type of modality to another are scarce.
- Trial name
- NCT01676272
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Solsys Medical LLC
Diabetic Foot Ulcers
A Comparative Efficacy Study of DermaPure™ to Treat Diabetic Foot Ulcers
This study has been designed to help determine how safe and effective DermaPure™ may be in treating hard-to-heal diabetic foot ulcers compared to the current standard of care.
- Trial name
- NCT02081352
- Testing
- DermaPure™, Standard care
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- TRx Wound Care Limited
Burns
Phase III Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in…
- Trial name
- NCT06745557
- Testing
- denovoSkin(TM), STSG
- Where
- 19 sites in Belgium, France and 7 more
- Volunteers
- 70 people
- Sponsor
- CUTISS AG
Diabetic Foot Ulcer (DFU), Ulcer Foot
Modified Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of Hard-to-Heal DFUs
The purpose of this study is to evaluate the efficacy of four dehydrated complete human placental membrane, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving…
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
- Trial name
- CAMPSTIM (NCT06449638)
- Testing
- Standard of Care, Revita, Relese
- Where
- 5 sites in United States
- Volunteers
- 272 people
- Sponsor
- StimLabs
Venous Leg Ulcers
Comparison of Human Allograft to Apligraf for Venous Leg Ulcers
Given the propensity for venous leg ulcers to become refractory, long standing lesions, incorporating active biologic grafts into the standard compression therapy, has shown to accelerate wound healing.
- Trial name
- NCT02047084
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Solsys Medical LLC
Diabetic Foot Ulcer, Lower Extremity Wound
DermACELL AWM® in Chronic Wagner Grade 3/4 Diabetic Foot Ulcers
This is a prospective, multicenter, clinical research trial evaluating the clinical outcomes of DermACELL AWM in dermal regeneration.
- Trial name
- NCT03044132
- Testing
- DermACELL AWM
- Where
- 2 sites in United States
- Volunteers
- 61 people
- Sponsor
- LifeNet Health
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Foot Ulcer, Diabetic
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety.
- Trial name
- NCT05586542
- Testing
- DERMASEAL, Plasma Film, Standard of Care
- Where
- 4 sites in United States
- Volunteers
- 26 people
- Sponsor
- Vitruvian Medical Devices, Inc.
Diabetic Foot Ulcer
DermACELL in Subjects With Chronic Wounds of the Lower Extremities
The study will compare treatment with DermACELL to conventional care in diabetic foot ulcers (DFU) and venous stasis ulcers (VSU).
- Trial name
- NCT01970163
- Testing
- DermACELL, GraftJacket, Conventional Care Dressings
- Where
- 12 sites in United States
- Volunteers
- 202 people
- Sponsor
- LifeNet Health
Burns
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.
- Trial name
- NCT03227146
- Testing
- EHSG-KF, STSG
- Where
- 6 sites in Italy, Netherlands and 1 more
- Volunteers
- 14 people
- Sponsor
- CUTISS AG
Diabetic Foot Ulcer (DFU), Ulcer Foot
Modified Platform Trial Assessing Multiple Umbilical Cord-based CAMPs and SOC v SOC Alone in the Treatment of Hard-to-Heal DFUs
The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in…
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer Foot, Diabetic Foot, Foot Ulcer
- Trial name
- CORDSTIM-DFU (NCT07449975)
- Testing
- Standard of Care (SOC), Corplex P, Theracor
- Volunteers
- 272 people
- Sponsor
- StimLabs
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Vasomotor Symptoms (VMS)
Dose Escalation Study in Female Subjects With Breast Cancer Receiving Aromatase Inhibitor or Tamoxifen
Open-label, two dose study of Q-122, over a 4 week treatment period to explore the effects of Q-122 in a population of women with a history of breast cancer taking an aromatase inhibitor or tamoxifen.
- Trial name
- NCT04080297
- Testing
- oral capsule of Q-122
- Volunteers
- 21 people
- Sponsor
- Que Oncology
Burns
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.
- Trial name
- NCT03229564
- Testing
- EHSG-KF, STSG
- Where
- 4 sites in Italy, Netherlands and 1 more
- Volunteers
- 12 people
- Sponsor
- CUTISS AG
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Skin Wound
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Full-Thickness Skin Defects in Adults and Children
This phase II trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and children with full-thickness Skin defects.
- Trial name
- NCT03394612
- Testing
- EHSG-KF, STSG
- Where
- 7 sites in Italy, Netherlands and 1 more
- Volunteers
- 21 people
- Sponsor
- CUTISS AG
Turner Syndrome, Short Stature Homeobox Gene Mutation
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and <18 years with open growth plates.
- Conditions
- Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery
- Trial name
- NCT07221851
- Testing
- Lonapegsomatropin [SKYTROFA®], Somatropin Pen Injector
- Where
- 51 sites in United States, France and 5 more
- Volunteers
- 186 people
- Sponsor
- Ascendis Pharma A/S