Clinical trials: Diabetic Foot Disease
Diabetic Foot Ulcer
Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.
The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care
- Trial name
- NCT01816672
- Testing
- AutoloGel, Usual and Customary Care
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Cytomedix
Diabetic Foot Ulcer
Prevention of Infection Using a Topical Gentamicin-Collagen Sponge in Diabetic Patients With An Uninfected Foot Ulcer
The purpose of this study is to determine the safety and efficacy of the topical gentamicin collagen sponge (gentamicin sponge) combined with standard of care (daily wound care, off-loading, diabetic control and debridement by a…
- Trial name
- NCT00658957
- Testing
- gentamicin-collagen sponge
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Innocoll
Diabetic Foot Ulcer, Venous Leg Ulcer
Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)
In participants with diabetic foot ulcers (DFUs), this study will assess complete wound closure by comparing synthetic hybrid-scale fiber matrix (Restrata®) with standard of care.
- Trial name
- NCT04927702
- Testing
- Synthetic Hybrid-Scale Fiber Matrix, Standard of Care, Living Cellular Skin Substitute
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Acera Surgical, Inc.
Peripheral Arterial Disease, Diabetic Foot Ulcer
Study of PDA-002 in Subjects With Peripheral Arterial Disease and Diabetic Foot Ulcers
This Phase 1, multicenter, open-label, dose-escalation study evaluated the safety and tolerability of intramuscular administration of PDA-002 (human placenta-derived cells) in subjects with peripheral arterial disease (PAD) and…
- Trial name
- NCT01859117
- Testing
- PDA-002
- Where
- 12 sites in United States
- Volunteers
- 15 people
- Sponsor
- Celularity Incorporated
Painful Diabetic Neuropathy, Diabetic Neuropathy
Study of Clonidine Hydrochloride Topical Gel, 0.1% in the Treatment of Pain Associated With Diabetic Neuropathy
The purpose of the study is to determine whether clonidine gel is an effective treatment for reducing the pain associated with painful diabetic neuropathy.
- Conditions
- Painful Diabetic Neuropathy, Diabetic Neuropathy, Neuropathy
- Trial name
- NCT02068027
- Testing
- Clonidine Gel 0.1%
- Where
- 23 sites in United States
- Volunteers
- 260 people
- Sponsor
- BioDelivery Sciences International
Diabetic Foot Ulcer
Evaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers.
The goal of this clinical trial is to learn if using perinatal tissue allografts improves healing of chronic, non-healing foot ulcers in diabetic patients.
- Trial name
- NCT06437028
- Testing
- Dual-layer perinatal tissue allograft, Three-layer fenestrated perinatal tissue allograft, Standard of care
- Where
- United States
- Volunteers
- 170 people
- Sponsor
- Samaritan Biologics
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
Diabetic Foot Ulcers (DFUs)
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
The goal of this clinical trial is to learn if drug Nu-3 works to treat mildly infected diabetic foot ulcers in adults with Type 1 or Type 2 diabetes at 3 different dose levels. It will also learn about the safety of drug Nu-3.
- Trial name
- NCT07565506
- Testing
- Antimicrobial agent
- Where
- 6 sites in United States
- Volunteers
- 24 people
- Sponsor
- Lakewood-Amedex Inc
Diabetic Foot Ulcer
A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial
This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months
- Trial name
- NCT06141811
- Testing
- ALLO-ASC-DFU, Vehicle sheet
- Where
- 4 sites in South Korea
- Volunteers
- 104 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers
The purpose of the following prospective, randomized, controlled clinical trial is to compare synthetic hybrid-scale fiber matrix (Restrata®, Acera Surgical, Inc.) with standard of care in treating diabetic foot ulcers in human…
- Trial name
- NCT04918784
- Testing
- Restrata®, Wound Dressing
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Acera Surgical, Inc.
Diabetic Foot Ulcer
Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.
- Trial name
- NCT02619877
- Testing
- ALLO-ASC-DFU, Standard therapy
- Where
- 4 sites in South Korea
- Volunteers
- 59 people
- Sponsor
- Anterogen Co., Ltd.
Diabetic Foot Ulcer
The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial…
- Trial name
- NCT00765063
- Testing
- Fragmin
- Where
- 27 sites in Austria, Belgium and 12 more
- Volunteers
- 62 people
- Sponsor
- Pfizer
Diabetic Foot Ulcer (DFU)
A Study to Evaluate Safety and Efficacy of APO-2 at Three Different Doses in Patients With Diabetic Foot Ulcer
The MARSYAS II study which will be conducted in patients with diabetic foot ulcer (DFU) consists of a Lead-In Phase for safety assessment of multiple doses of the biologic investigational medicinal product (IMP) APO-2 and of a…
- Trial name
- NCT04277598
- Testing
- APO-2
- Where
- 14 sites in Austria, Czechia and 2 more
- Volunteers
- 159 people
- Sponsor
- Aposcience AG
Diabetic Foot Ulcer
A RCT to Compare the Effects of Two Wound Products on Biofilm Disruption in DFUs
This study is a prospective comparative study to determine if an Iodine Gel (Iodosorb◊) is better than standard dressing (Solosite◊ gel) in disruption of biofilm (small microorganism bacteria similar to plaque on teeth) on the…
- Trial name
- NCT02181621
- Testing
- Iodosorb, Solosite gel
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Smith & Nephew, Inc.
Acute and Chronic Wounds, Pressure Ulcers
Clinical Evaluation of the SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of…
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers
- Trial name
- NCT01113658
- Testing
- SNaP Wound Care System
- Where
- 2 sites in United States
- Sponsor
- 3M
Diabetic Foot Ulcer
FeetSee Thermal Images Collection Protocol in Diabetes Patients
Diabetic foot ulcers (DFUs) are a major cause of morbidity, lower-extremity amputation and healthcare costs in people with diabetes.
- Trial name
- NCT07300163
- Testing
- FeetSee thermal camera
- Where
- 4 sites in Lithuania, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Diabetis JSC
Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Treatment
CHEMfoot: DEBRICHEM® in Chronic Diabetic Foot Wounds
This multicenter, randomized controlled trial will evaluate the effectiveness and safety of DEBRICHEM®, a topical desiccant gel, when added to standard care for chronic diabetic foot wounds.
- Conditions
- Diabetic Foot Ulcer (DFU), Diabetic Foot Ulcer Treatment, Diabetic Foot Wounds
- Trial name
- CHEMfoot (NCT07206862)
- Testing
- DEBRICHEM®
- Volunteers
- 242 people
- Sponsor
- DEBx Medical B.V.
Venous Leg Ulcer, Diabetic Foot Ulcer
A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers
This study will be a multicenter, prospective, open label, one-arm study intended to assess the clinical performance and safety of EX-02 in debridement of lower leg ulcers: Venous Leg Ulcers (VLU) and Diabetic Foot Ulcer (DFU).
- Trial name
- NCT04817228
- Testing
- EscharEx (EX-02 formulation)
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- MediWound Ltd
Diabetes Mellitus
Clinical Trial to Evaluate the Efficacy and Safety of the Use of Ozone Versus Sunflower Oil in Treating Diabetic Foot
This is a open, phase III, multicenter, prospective, comparative, controlled, randomized clinical trial to evaluate the efficacy and safety of the use of ozone released by Philozon Medplus device versus conventional therapy in…
- Trial name
- PHIOZO0110 (NCT01643967)
- Testing
- sunflower oil, Ozone Therapy
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Philozon Geradores de Ozonio LTDA
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