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
Burns, Ulcers
Clinical Application of Autologous Three-Cellular Cultured Skin Substitutes (CSS)
The aim of this work was to present the investigators experience in the use of autologous three-cellular cultured skin substitutes (CSS) consisting of cultured keratinocytes, melanocytes and fibroblasts attached to a scaffold of…
- Conditions
- Burns, Ulcers, Giant Nevi
- Trial name
- NCT00718978
- Testing
- CSS grafting
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- University of Roma La Sapienza
Burns
Comparison of Skin Substitutes Used in Burn Care
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts: 1. will reduce scar formation of skin grafts 2. will reduce burn wound contractures 3.
- Trial name
- Quad (NCT00676013)
- Testing
- Integra, AlloDerm, Homograft
- Where
- 2 sites in United States
- Volunteers
- 158 people
- Sponsor
- The University of Texas Medical Branch, Galveston
Epidermolysis Bullosa Dystrophica
Self-Assembled Skin Substitute for the Treatment of Epidermolysis Bullosa
Single patient study. Patient diagnosed with dystrophic epidermolysis bullosa presenting chronic open wounds that are not responding to dressings, topical preparations (antimicrobials, antibiotics) and systemic agents…
- Trial name
- SASS (NCT04171661)
- Testing
- SASS
- Where
- Canada
- Volunteers
- 1 people
- Sponsor
- CHU de Quebec-Universite Laval
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
Full Thickness Burn
Permeaderm Versus Homograft for Full-thickness Burns
Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major storage spaces in comparison to…
- Trial name
- NCT04673435
- Testing
- PermeaDerm for temporary coverage, FHCA for temporary coverage, PermeaDerm over autograft
- Where
- United States
- Sponsor
- The University of Texas Medical Branch, Galveston
Wounds
Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds
Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.
- Trial name
- TB4 (NCT02668055)
- Testing
- TB4
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chinese PLA General Hospital
Burn, Traumatic Implants
Long Term Evaluation of Human Acellular Dermal Matrix Allograft For Coverage of the Wound After Extensive Deep Burn
The present study was to retrospectively evaluate the long-term outcomes of the cograft acellular dermal matrix (ADM) with autologous thin split-thickness skin for coverage of functional regional wounds in burned patients.
- Trial name
- ADM (NCT01562119)
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Tang-Du Hospital
Burns
SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma
This clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent…
- Trial name
- NCT02350205
- Testing
- Self assembled skin substitute (SASS)
- Where
- 8 sites in Canada
- Volunteers
- 52 people
- Sponsor
- CHU de Quebec-Universite Laval
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, Pressure Ulcer
A Real-World Registry of Chronic Wounds and Ulcers
WOUNDJOURNEY is a longitudinal, real-world, observational registry designed to capture the full clinical course and patient journey associated with chronic wounds and ulcers.
- Conditions
- Diabetic Foot, Pressure Ulcer, Surgical Wound Dehiscence, Vasculitis
- Trial name
- WOUNDJOURNEY (NCT02280733)
- Testing
- Usual care
- Where
- United States
- Volunteers
- 300,000 people
- Sponsor
- U.S. Wound Registry
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
RDEB, Recessive Dystrophic Epidermolysis Bullosa
GMEB-SASS: A Gene-Modified Skin Substitute for RDEB Treatment
This study is being done to find out if a new type of skin graft, called GMEB-SASS, is safe and effective for helping wounds heal in people with RDEB (Recessive Dystrophic Epidermolysis Bullosa).
- Conditions
- RDEB, Recessive Dystrophic Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Recessive
- Trial name
- NCT07193134
- Testing
- Genetically Modified Epidermolysis Bullosa Self-Assembled Skin Substitute (GMEB-SASS)
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- CHU de Quebec-Universite Laval
Burn Injury, Soft Tissue Injury
Phase I Study for Autologous Dermal Substitutes and Dermo-epidermal Skin Substitutes for Treatment of Skin Defects
The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed…
- Conditions
- Burn Injury, Soft Tissue Injury, Skin Necrosis, Scars
- Trial name
- NCT02145130
- Testing
- denovoDerm, denovoSkin
- Where
- 2 sites in Switzerland
- Volunteers
- 12 people
- Sponsor
- University of Zurich
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
Difficult to Heal Wounds
The Activity of Tissue Engineering Skin Substitutes
The main purpose of this experiment was to evaluate the activity of tissue engineering skin substitutes safety and efficacy studies for the treatment of difficult to heal wounds
- Trial name
- MSCs (NCT02668042)
- Testing
- liveness tissue skin
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chinese PLA General Hospital
Wounds
Study of Donated Amnion, Fetal Placental Membrane, as Skin Substitute for Burn Patients
Is the use of fetal membrane (human amnion) as a transient wound coverage in wound repair safe and efficacious. Will the incorporation of liposomal gene constructs to amnion enhance the functionality of human amnion and improve…
- Trial name
- Amnion (NCT00592189)
- Testing
- blood draw
- Where
- United States
- Volunteers
- 1,164 people, healthy volunteers welcome
- Sponsor
- The University of Texas Medical Branch, Galveston
Recessive Dystrophic Epidermolysis Bullosa
A Pilot Study to Evaluate a Temporary Skin Substitute (Spincare® Matrix) for Wound Healing in RDEB Patients
Recessive dystrophic epidermolysis bullosa (RDEB) is a subtype of epidermolysis bullosa (EB), an inherited skin condition that presents with blistering skin.
- Trial name
- RDEB (NCT05944250)
- Testing
- Spincare matrix
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Stanford University