Clinical trials: Chronic Skin Ulcers
Chronic Venous Disease, Varicose Ulcer
Effects of Local Insulin on Varicose Ulcers for Wound Healing
A randomized, split-plot, double-blind, placebo-controlled trial. The varicose ulcer is divided into two (side A and B). Half of the wound's surface is treated locally with insulin (Glargine) applied at an approx depth of 3-4 mm.
- Conditions
- Chronic Venous Disease, Varicose Ulcer, Wound Healing, Insulin
- Trial name
- NCT04310280
- Testing
- Insulin Glargine, Saline
- Where
- Mexico
- Volunteers
- 13 people
- Sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
Skin Ulcer
The Regeneration Effects of Derma-PACE Shockwave in Chronic Diabetic Ulcers
Management of chronic diabetic foot skin ulcers require multidisciplinary approaches including diabetic control, wound care, antibiotic, shoe wear off-loading, and surgery in selected cases.
- Trial name
- NCT01219127
- Testing
- Derma-PACE
- Volunteers
- 100 people
- Sponsor
- Chang Gung Memorial Hospital
Diabetic Foot Ulcer, Pressure Ulcer
A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1
The study is a prospective, single arm, multicenter efficacy study, consisting of 60 subjects who will complete the study (note: if any patients are lost to follow-up or withdrawn, enrollment will increase to compensate for loss…
- Conditions
- Diabetic Foot Ulcer, Pressure Ulcer, Venous Leg Ulcer, Trauma Injury
- Trial name
- NCT04577183
- Testing
- RD1 System
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- RedDress Ltd.
Obliterans, Arteriosclerosis, Peripheral Arterial Disease
Combined Treatment for Non-Healing Wounds in Chronic Lower Extremity Arterial Disease: A Comparative Study
Endovascular interventions, such as balloon angioplasty and stenting, are commonly used for PAD due to their proven safety and effectiveness. However, traditional treatments for chronic non-healing wounds are often insufficient.
- Conditions
- Obliterans, Arteriosclerosis, Peripheral Arterial Disease, Diabetic Foot
- Trial name
- NCT06724276
- Testing
- balloon angioplasty and stenting of lower extremity vessels + fibroblasts, balloon angioplasty and stenting of lower extremity vessels
- Where
- Kazakhstan
- Volunteers
- 116 people
- Sponsor
- Tulip Medicine
Foot Ulcer, Diabetic
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
- Trial name
- NCT02675855
- Testing
- GrafixPRIME®, Dressing Application, Off-loading (walking boot)
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Osiris Therapeutics
Deep Vein Thrombosis, Venous Stasis
Chronic Venous Thrombosis: Relief With Adjunctive Catheter-Directed Therapy (The C-TRACT Trial)
The purpose of this study is to determine if the use of image-guided, endovascular therapy (EVT) is an effective strategy with which to reduce Post Thrombotic Syndrome (PTS) disease severity and improve quality of life in…
- Conditions
- Deep Vein Thrombosis, Venous Stasis, Venous Insufficiency, Venous Leg Ulcer
- Trial name
- C-TRACT (NCT03250247)
- Testing
- Stents
- Where
- 29 sites in United States
- Volunteers
- 225 people
- Sponsor
- Washington University School of Medicine
Ulcer, Venous Ulcer
ECM and Blood Components for Wound Healing
The Extracellular Matrix (ECM) and Blood Components for Wound Healing feasibility study is a clinical trial approved by Health Canada to study the safety of extracellular matrix (ECM) and autologous blood products in wound…
- Conditions
- Ulcer, Venous Ulcer, Foot Ulcer, Diabetic
- Trial name
- NCT01909908
- Testing
- ECM, Blood Products, ECM in Blood Products
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Cook Group Incorporated
Rheumatoid Arthritis, Ankylosing Spondylitis
Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases
TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be…
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus, Psoriasis
- Trial name
- TRANSREG (NCT01988506)
- Testing
- Interleukin 2
- Where
- 11 sites in France
- Volunteers
- 81 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Chronic Diabetic Foot Ulcers
Shockwave Treatment of Diabetic Foot Ulcer: Step I
Extracorporeal Shock Wave treatment is a well established treatment in orthopedics. Considerable success has been reported after treatment of various soft tissue pathologies (Tendinitis, heel spur etc).
- Trial name
- STUF (NCT00954343)
- Testing
- Extracorporeal Shock Wave
- Where
- Germany
- Sponsor
- Technical University of Munich
Ulcer, Leg Ulcer
Study of VF001-DP in Patients With Chronic Venous Leg Ulcers
The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.
- Conditions
- Ulcer, Leg Ulcer, Varicose Ulcer, Pathologic Processes
- Trial name
- NCT02973893
- Testing
- VF001-DP LD, VF001-DP HD
- Where
- 17 sites in United States
- Volunteers
- 156 people
- Sponsor
- Factor Therapeutics Ltd.
Diabetic Foot Ulcer (DFU), Amnio-Maxx
Effect of Amnio-Maxx on the Healing Rate of Chronic Diabetic Foot Ulcers.
This study will evaluate a cellular, acellular, matrix-like product (CAMP) and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).
- Trial name
- NCT07209475
- Testing
- Amnio-Maxx® Dual Layer Amnion Patch, Standard of Care (Investigator Choice)
- Where
- 8 sites in United States
- Volunteers
- 248 people
- Sponsor
- Royal Biologics
Surgical Incision, Ulcer Foot
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
This is a prospective, multi-center, open label study evaluating the performance of PICO14 Negative Pressure Wound Therapy (NPWT) in the management of chronic open wounds (pressure ulcers, venous leg ulcers, diabetes related foot…
- Conditions
- Surgical Incision, Ulcer Foot, Ulcer Venous, Ulcer, Leg
- Trial name
- PICO14 (NCT05234632)
- Testing
- PICO 14 single-use Negative Pressure Wound Therapy System
- Where
- 6 sites in Germany, United Kingdom
- Volunteers
- 45 people
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcers
Grafix® DFU: Open-Label Extension Option to Evaluate Safety & Efficacy of Grafix® for Chronic Diabetic Foot Ulcers
The primary objective of the present study is to further establish in a randomized controlled trial, the safety and efficacy of weekly Grafix® administration versus control in patients with chronic diabetic foot ulcers.
- Trial name
- DFU (NCT01596920)
- Testing
- Tissue, Control
- Where
- 15 sites in United States
- Volunteers
- 97 people
- Sponsor
- Osiris Therapeutics
Venous Leg Ulcer
Effect of VarIthena on Wound Healing in Venous Leg Ulcers (VLU)
A 12 month, multicenter, open-label registry to observe chronic venous insufficiency resulting in VLU treated with Varithena.
- Trial name
- VIEW-VLU (NCT03257254)
- Testing
- Varithena
- Where
- 14 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Boston Scientific Corporation
Lower Extremity, Chronic Ulcers
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Lower Extremity Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic lower extremity wounds.
- Conditions
- Lower Extremity, Chronic Ulcers, Pressure Ulcer (PU), Venous Leg Ulcer (VLU)
- Trial name
- NCT07862335
- Testing
- PRFM
- Volunteers
- 30 people
- Sponsor
- Tiger Biosciences, LLC.
Diabetic Foot Ulcers, Venous Stasis Ulcer
Cellular and Tissue Based Therapy Registry
The goal of the Cellular and Tissue Based Therapy Registry (CTPR) for Wounds is to provide real world patient data from electronic health records submitted to meet Stage 2 Meaningful Use in order to understand the value of these…
- Conditions
- Diabetic Foot Ulcers, Venous Stasis Ulcer, Pressure Ulcer, Chronic Non Healing Wound
- Trial name
- CTPR (NCT02322554)
- Testing
- Cellular and tissue based products
- Where
- United States
- Volunteers
- 50,000 people
- Sponsor
- U.S. Wound Registry
Venous Leg Ulcer
Clinical Study Of Affinity Versus SOC In The Management Of VLUs
This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs.
- Trial name
- NCT04901013
- Testing
- Affinity
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Diabetic Foot Ulcer, Non-healing Wound
An Observational Clinical Trial Examining the Effect of Topical Oxygen Therapy (NATROX™) on the Rates of Healing of Chronic Diabetic Foot Ulcers
This study aims to evaluate the effectiveness of NATROX™ Topical Oxygen Wound Therapy for subjects with non-healing foot ulceration. Subjects will be treated with standard care for 4 weeks.
- Trial name
- NCT03863054
- Testing
- NATROX™ Topical Oxygen Therapy System
- Where
- Singapore
- Volunteers
- 20 people
- Sponsor
- Singapore General Hospital
Foot Ulcer, Diabetic
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
This study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
- Trial name
- NCT02563522
- Testing
- Engensis (VM202)
- Where
- 22 sites in United States
- Volunteers
- 44 people
- Sponsor
- Helixmith Co., Ltd.
Charcot Joint of Foot, Osteoarthropathy
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot foot, characterized by progressive destructive damage to bone, soft tissue and tendons, involving joint dislocation in the ankle and foot, is a complication of diabetes that is still poorly understood by patients and…
- Trial name
- CHARQUAM (NCT05491577)
- Testing
- Filling in the SF-36, FAAM-F, PHQ-9, PHQ-2 and the simplified version of the EPICES score questionnaire
- Where
- 17 sites in France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes