Clinical trials: Skin Graft Complications
Diabetic Foot Ulcer
Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
The objective of this study is to evaluate the percentage of patients with complete diabetic foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human amnion/chorion membrane (dHACM) plus…
- Trial name
- NCT01693133
- Testing
- Standard of Care: Moist Wound Therapy and Offloading, EpiFix plus Standard of Care
- Where
- 20 sites in United States
- Volunteers
- 132 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcer, Venous Leg Ulcer
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.
- Trial name
- NCT06236750
- Testing
- EPIFIX
- Where
- 5 sites in Japan
- Volunteers
- 75 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot Ulcers, Venous Ulcers
Registry Trial of the Effectiveness of Platelet Rich Plasma for Chronic Non-Healing Wounds
This study will examine differences in the process of wound-healing in patients treated with platelet rich plasma (a concentration of proteins derived from a patients own blood) applied to the wound as a gel; injected into the…
- Conditions
- Diabetic Foot Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- CMS (NCT02071979)
- Testing
- Autologous PRP Gel, Autologous PRP Injections, Autologous PRP Gel plus PRP Injections
- Where
- 6 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Arteriocyte, Inc.
Ulcer Healing, Diabetic Foot Ulcer
Evaluating The Efficacy Of A Keratin Graft In Treating Non-Healing Diabetic Foot Ulcers
The goal of this clinical pilot is to collect patient outcome data on a commercially available, keratin-based skin substitute matrix: ProgenaMatrix®.
- Trial name
- NCT05797285
- Testing
- human keratin graft
- Where
- 3 sites in United States
- Volunteers
- 26 people
- Sponsor
- ProgenaCare Global, LLC
Superficial Partial Thickness Burn, Skin Graft; Complications
Nitric Oxide Generating Gel Dressing in Patients With Superficial Partial Thickness Wounds
This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects on the body including vasodilation and angiogenesis.
- Trial name
- ProNOx2 (NCT01983085)
- Testing
- NOx dressing, Standard of Care
- Where
- 2 sites in United Kingdom
- Volunteers
- 13 people
- Sponsor
- Edixomed Ltd
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Diabetic Foot Ulcer
Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers
- Trial name
- NCT07039396
- Testing
- NeoThelium FT (HCT/P 361)
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- NuScience Medical Biologics, LLC
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.
Surgery-Complications
Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement
Registry Objectives The overall objective of the registry is to collect quality and safety data to assess the long-term outcomes of Kerecis Omega3 SurgiBind in surgical procedures to reinforce soft tissue and prevent surgical…
- Trial name
- NCT05898711
- Testing
- Fish skin graft
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Kerecis Ltd.
Diabetic Foot Ulcer
Nitric Oxide Generating Gel Dressing in Patients With Diabetic Foot Ulcers
This is a 2 part study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on chronic diabetic foot ulcers (DFU). Nitric oxide has a range of effects on the body including vasodilation and angiogenesis.
- Trial name
- ProNOx1 (NCT01982565)
- Testing
- NOx dressing, Standard of Care
- Where
- 10 sites in United Kingdom
- Volunteers
- 130 people
- Sponsor
- Edixomed Ltd
Diabetic Foot Ulcer (DFU), Chronic Foot Ulcers
Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in…
- Trial name
- NCT06681428
- Testing
- Allograft
- Where
- 9 sites in United States
- Volunteers
- 240 people
- Sponsor
- Tides Medical
Diabetic Foot Ulcer
Comparative Study of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether the EpiFix human amniotic membrane is effective in the treatment of diabetic foot ulcers.
- Trial name
- NCT01552499
- Testing
- Standard of care, Applications of EpiFix
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- MiMedx Group, Inc.
Diabetic Foot
Efficacy of Human Placental Graft in Diabetic Foot Ulcers
To determine the efficacy of full-thickness placental allograft in chronic wound healing
- Trial name
- NCT03708029
- Testing
- Revita Allograft
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- StimLabs
Donor Site Complication
TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
Primary objective: 1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding) 2.
- Trial name
- NCT02737748
- Testing
- TWB-103 Group
- Where
- 3 sites in Japan, Taiwan
- Volunteers
- 48 people
- Sponsor
- Transwell Biotech Co., Ltd.
Wound Heal
Performance, Safety and Efficacy of PICO Device.
The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the…
- Trial name
- NCT03698968
- Testing
- Negative Pressure Wound Therapy
- Where
- 11 sites in Switzerland, United Kingdom
- Volunteers
- 50 people
- Sponsor
- Smith & Nephew, Inc.
Wound
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border
The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact…
- Trial name
- NCT03877484
- Testing
- ALLEVYN Gentle border
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 43 people
- Sponsor
- Smith & Nephew Orthopaedics AG
Diabetic Foot Ulcer
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.
- Trial name
- NCT01657474
- Testing
- Weekly application of EpiFix plus standard of care, Biweekly application of EpiFix plus standard of care
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- MiMedx Group, Inc.
Wounds, Pressure Ulcer
Kerecis Real-World Fish Skin Graft Registry
Multi-center, observational (i.e., non-interventional), open-label, real-world Registry on the Use of Kerecis Devices
- Conditions
- Wounds, Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- ISACOD (NCT06384183)
- Testing
- Kerecis Fish Skin Graft
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- Kerecis Ltd.
Diabetic Foot Ulcer
Omega3 Wound Fish Skin Graft in the Treatment of DFUs
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound.
- Trial name
- NCT04133493
- Testing
- Kerecis Omega3 Wound, Fibracol
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Kerecis Ltd.
Diabetic Foot Ulcer, Venous Leg Ulcer
PLASOMA Ultimate Safety & Efficacy Study
The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: 1. Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. 2.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Burn Wound
- Trial name
- PULSE (NCT04828304)
- Testing
- PLASOMA
- Where
- 6 sites in Netherlands
- Volunteers
- 101 people
- Sponsor
- Plasmacure