Clinical trials: Chronic Diabetic Foot Ulcers
Foot Ulcer, Diabetic
Evaluation of a Medical Food for Chronic Wounds
The study objective is to compare outcomes in subjects with a diabetic foot ulcer after 16 weeks of consuming a medical food versus a calorically similar control drink.
- Trial name
- NCT00711217
- Testing
- Medical Food, Drink mix calorically similar to experimental product
- Where
- 51 sites in United States, Spain and 2 more
- Volunteers
- 271 people
- Sponsor
- Abbott Nutrition
Peripheral Arterial Disease, Peripheral Vascular Disease
Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia
The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb…
- Conditions
- Peripheral Arterial Disease, Peripheral Vascular Disease, Critical Limb Ischemia
- Trial name
- NCT00956332
- Testing
- MultiGeneAngio
- Where
- 7 sites in Israel
- Volunteers
- 28 people
- Sponsor
- MultiGene Vascular Systems Ltd.
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
Diabetic Foot Ulcer, Wagner Grade 1 - 2
Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers
ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the…
- Conditions
- Diabetic Foot Ulcer, Wagner Grade 1 - 2, Chronic Wound, Open Wound
- Trial name
- NCT07396376
- Testing
- ELU42 Topical Spray
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Eluciderm Inc
Wounds
The Use of CureXcellTM in a Community Setting for the Treatment of Hard to Heal Wounds
The primary objective of the study is to define procedures for the use of CureXcellTM in the community through Clalit Health Services.
- Trial name
- NCT01113307
- Testing
- Activated allogeneic white blood cells
- Where
- 7 sites in Israel
- Volunteers
- 131 people
- Sponsor
- Macrocure Ltd.
Pressure Ulcer, Foot Ulcer, Diabetic
Use of Santyl Within an Accountable Care Organization
This study is designed to assess the comparative effectiveness of SANTYL® versus standard of care in the treatment of pressure ulcers and diabetic foot ulcers within the continuum of care of an ACO.
- Trial name
- NCT02716519
- Testing
- Santyl, Standard Care
- Where
- United States
- Sponsor
- Smith & Nephew, Inc.
Diabetic Foot Ulcer
Efficacy and Safety Study in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to determine the safety and efficacy of Dermal-LSR plus Standard of Care (SOC) for the treatment of diabetic foot ulcers (DFU)in comparison to the treatment to SOC alone.
- Trial name
- NCT00387101
- Testing
- Dermal - Living Skin Replacement (Dermal - LSR)
- Where
- 12 sites in United States
- Volunteers
- 288 people
- Sponsor
- ApoPharma
Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diabetic foot ulcers (DFUs) and…
- Trial name
- STRIDDDE (NCT06939686)
- Testing
- Miro3D Wound Matrix, Standard of Care (SOC)
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Reprise Biomedical, Inc.
Diabetic Foot Ulcer
High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers
Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was…
- Trial name
- NCT04300205
- Testing
- High intensity LED light device
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- Illumacell Inc.
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
Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs)
Real-World Effectiveness of Amniotic Membrane Allografts Versus Standard Wound Care in DFU, VLU, and PU
This observational study will evaluate the real-world effectiveness of four amniotic membrane-based products (Zenith™, Orion™, SurGraft FT™, Complete ACA™) in addition to standard care, compared with standard care alone.
- Conditions
- Diabetic Foot Ulcer (DFU), Venous Leg Ulcers (VLUs), Pressure Ulcers, Bedsores, Decubitus Ulcer
- Trial name
- NCT07223281
- Where
- 4 sites in United States
- Volunteers
- 2,400 people
- Sponsor
- Legacy Medical Consultants
Chronic Ulcers: Non-healing Deep Cavity Wounds (e.g., Diabetic Foot Ulcers, Arterial Ulcers, Post-surgical Wound Healing Disorders)
INJECTHEAL - Investigation of Chronic Wound Exudate and Biofilm
This prospective observational study will collect routine clinical waste material from 72 adults with chronic, non-healing wounds, including wound exudate from negative pressure therapy containers or sponges and wound…
- Trial name
- INJECTHEAL (NCT07745764)
- Testing
- standard of care
- Where
- Germany
- Volunteers
- 72 people
- Sponsor
- Barbara Wolff-Winiski
Diabetic Foot Ulcer
Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers
The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.
- Trial name
- VHTDFU2 (NCT04210609)
- Testing
- Vaporous Hyperoxia Therapy
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vaporox
Platelet-Derived Growth Factor, Diabetic Foot
Evaluation of the Safety Follow-up of Becaplermin or Placebo Gel Following Treatment of Chronic, Full Thickness Diabetic Ulcers
The purpose of this study is to retrospectively evaluate the safety of sterile becaplermin gel compared with sterile placebo gel treatment 12 months or more after the last dose was administered in 1 of 2 double-blind trials…
- Conditions
- Platelet-Derived Growth Factor, Diabetic Foot, Neoplasms
- Trial name
- NCT00740922
- Volunteers
- 563 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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, Chronic Ulcers of the Lower Limb
Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds
The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers.
- Trial name
- NCT07444593
- Testing
- Biodynamik XT3
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Biodynamik, Inc
Diabetic Foot Ulcers
A Study to Investigate the Safety and Clinical Effect of Nexagon® as a Topical Treatment for Subjects With a Diabetic Foot Ulcer (DUNE)
This study is for Type I or Type II diabetic subjects with with a diabetic foot ulcer. The study is being done to determine if Nexagon® plus standard of care is more effective than placebo plus standard of care.
- Trial name
- DUNE (NCT01490879)
- Testing
- Nexagon® Low Dose, Nexagon® Medium Dose, Nexagon® High Dose
- Where
- 25 sites in United States, Russia and 1 more
- Volunteers
- 168 people
- Sponsor
- OcuNexus Therapeutics, Inc.
Venous Leg Ulcer, Diabetic Foot Ulcer
Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With Standard of Care
A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will…
- Trial name
- BISIL (NCT05786612)
- Testing
- Biatain® Silicone, Mepilex Border with Aquacel Extra Hydrofiber
- Where
- 9 sites in United Kingdom
- Volunteers
- 102 people
- Sponsor
- Coloplast A/S
Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft
a Prospective, Multicenter, Randomized Controlled Trial, With a Non-randomized Sentinel Cohort, Evaluating the Efficacy of Bioxheal, a Single-layer Placental-derived Biologic in Nonhealing Diabetic Foot Ulcers
BIOxHEAL is an investigational placental-derived biologic being evaluated for the treatment of nonhealing diabetic foot ulcers. Adults with type 1 or type 2 diabetes who have a diabetic foot ulcer that has not healed with…
- Conditions
- Diabetic Foot Ulcer, Amniotic Membrane Placental Allograft, Biologic
- Trial name
- AB BIOH - DFU (NCT07852338)
- Testing
- Standard of Care, BIOxHEAL (human amniotic membrane allograft)
- Where
- United States
- Volunteers
- 253 people
- Sponsor
- Applied Biologics, LLC
Diabetic Foot Ulcer
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
- Trial name
- FEENICS (NCT00662831)
- Testing
- Fragmin/ Dalteparin Sodium
- Where
- 63 sites in Austria, Belgium and 15 more
- Volunteers
- 276 people
- Sponsor
- Pfizer