Clinical trials: Diabetic Ulcers
Diabetic Foot, Quality of Life
Patient Empowerment Study
The Patient Empowerment Study is an observational longitudinal study among adults with diabetic foot ulcer (DFU). The scope of this study is to better understand how a patient's DFU disease process and usage of the Podimetrics…
- Conditions
- Diabetic Foot, Quality of Life, Mental Health Wellness 1, Ulcer Foot
- Trial name
- NCT04537676
- Testing
- No intervention, this is an observational study
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Podimetrics, Inc.
Diabetic Foot Ulcer
RESPOND Restoring Equilibrium and Wound Stimulation to Promote Healing Of Non-healing DFUs
To evaluate the safety and effectiveness of MIST Therapy in conjunction with Standard of Care (SOC) compared to Standard of Care alone in the treatment of diabetic foot ulcers (DFU).
- Trial name
- NCT01608776
- Testing
- MIST Therapy, SOC - Standard of Care
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Celleration, Inc.
Diabetic Polyneuropathy, Diabetic Foot Ulcer
TempTouch IR Thermometry & Diabetic Patient Self-Care
Foot ulcers develop in diabetics with neuropathy because of cumulative injury over the course of several days. These patients do not feel pain, and do not recognize their foot is being injured until a wound develops.
- Conditions
- Diabetic Polyneuropathy, Diabetic Foot Ulcer, Diabetes, Foot Infection
- Trial name
- NCT00289497
- Testing
- TempTouch®
- Where
- 3 sites in United States
- Volunteers
- 180 people
- Sponsor
- Diabetica Solutions Inc.
Non-healing Wound, Non-healing Diabetic Foot Ulcer
Phase 2 Pilot Trial of Subjects With Complex Non-healing Diabetic Foot Ulcers Treated With Standard Care Plus Cryopreserved Umbilical Cord Allograft (TTAX01)
It is hypothesized that application of the human placental umbilical cord tissue TTAX01 to the surface of a well debrided, complex diabetic foot ulcer will, with concomitant management of infection, result in a higher proportion…
- Conditions
- Non-healing Wound, Non-healing Diabetic Foot Ulcer, Diabetic Foot Infection
- Trial name
- NCT03230175
- Testing
- TTAX01, Surgical resection and debridement, Systemic antibiotics
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- BioTissue Holdings, Inc
Diabetic Foot Ulcers
Evaluation of Woulgan in Diabetic Foot Ulcer
The aim of the current study is to support the performance and safety of Woulgan® in the treatment of diabetic foot ulcer in comparison with the commercially available hydrogel Intrasite.
- Trial name
- NCT02631512
- Testing
- Woulgan Gel, Intrasite Hydrogel
- Where
- 3 sites in Sweden, United Kingdom
- Volunteers
- 62 people
- Sponsor
- Biotec Pharmacon ASA
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec Inc.
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Diabetic Foot Ulcers
A Clinical Study of the Safety and Efficacy of MEBO Wound Ointment in Subjects With Diabetic Foot Ulcers
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
- Trial name
- NCT01070433
- Testing
- MEBO Wound Ointment (MEBO), Standard of Care
- Where
- 9 sites in United States
- Volunteers
- 75 people
- Sponsor
- Skingenix, Inc.
Diabetic Foot Ulcer
A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers
This prospective case series is to gain additional clinical experience in the treatment of diabetic foot ulcers, by documenting and relating patient history (including baseline wound characteristics) and clinical outcomes…
- Trial name
- NCT02799121
- Testing
- ReGenerCell™ Autologous Cell Harvesting Device
- Where
- 3 sites in United Kingdom
- Volunteers
- 16 people
- Sponsor
- Avita Medical
Diabetes, Diabetic Foot
Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care
This is a two-armed randomized controlled trial (RCT) primarily aimed at determining if application of Cytal Wound Matrix 1-Layer intervention to diabetic foot ulcers shows improved wound closure rates when compared to standard…
- Conditions
- Diabetes, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
- Trial name
- NCT03626623
- Testing
- Cytal Wound Matrix 1-Layer, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Integra LifeSciences Corporation
Diabetic Foot, Diabetic Foot Ulcer
Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200
Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).
- Conditions
- Diabetic Foot, Diabetic Foot Ulcer, Diabetic Foot Ulcer Neuropathic
- Trial name
- NCT06003530
- Testing
- hOMSC200
- Where
- Israel
- Volunteers
- 21 people
- Sponsor
- Cytora Ltd.
Diabetic Foot Ulcer (DFU)
A Study Comparing an Investigational Wound Gel With Standard Treatment for Mild to Moderate Diabetic Foot Ulcers
The goal of this clinical investigation is to evaluate if VES-0-D (an investigational wound gel) works to treat mild to moderate Diabetic Foot Ulcers.
- Trial name
- AIM-DFU (NCT07783087)
- Testing
- VES-0-D wound gel, Standard of Care (Investigator Choice)
- Where
- 8 sites in Belgium
- Volunteers
- 64 people
- Sponsor
- Flen Health
Chronic Diabetic Foot Ulcer
Clinical Evaluation of DCB-WH1 in Healing of Chronic Diabetic Foot Ulcers
The primary objective of this Phase 2 study is to evaluate the efficacy of DCB-WH1 ointment in wound closure as compared to vehicle control when applied topically to chronic diabetic foot ulcers for 12 weeks.
- Trial name
- NCT00709514
- Testing
- DCB-WH1 ointment
- Where
- Taiwan
- Volunteers
- 41 people
- Sponsor
- Oneness Biotech Co., Ltd.
Wounds and Injuries, Diabetes Complications
Safety and Efficacy Study of MedCu Wound Dressings
The Study was divided into three Phases: Screening Phase (1-2 weeks); Treatment Phase (~ 1 month); and Follow-up Phase (two weeks).
- Trial name
- NCT04963998
- Testing
- Application of Wound Dressings with Copper Oxide
- Where
- Israel
- Volunteers
- 13 people
- Sponsor
- MedCu Technologies Ltd.
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
Clinical Investigation of Galnobax® for the Treatment of Diabetic Foot Ulcers
The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU).
- Trial name
- NCT01113515
- Testing
- Esmolol hydrochloride
- Where
- 5 sites in United States, India and 1 more
- Volunteers
- 44 people
- Sponsor
- Novalead Pharma Private Limited
Diabetic Foot Ulcer
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R).
- Trial name
- NCT01181453
- Testing
- Dermagraft, Comparator
- Where
- United States
- Volunteers
- 314 people
- Sponsor
- Organogenesis
Wound Heal, Ulcer
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
A multi-center, prospective, observer-blinded, randomized controlled clinical trial to evaluate the efficacy of PPECM augmented standard of care versus standard of care alone in the management of hard-to-heal diabetic foot ulcers.
- Trial name
- IDEAL (NCT06616844)
- Testing
- InnovaMatrix® AC
- Where
- 21 sites in United States
- Volunteers
- 235 people
- Sponsor
- ConvaTec Inc.
Foot Ulcer, Diabetic
A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without…
- Trial name
- NCT01270633
- Testing
- PriMatrix, Standard of Care
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 30 people
- Sponsor
- Integra LifeSciences Corporation
Diabetes Mellitus Foot Ulcer
Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.
Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions.
- Trial name
- NCT05604352
- Testing
- DiaSole
- Volunteers
- 30 people
- Sponsor
- Kaydiar Ltd