Clinical Trials Logo

Diabetic Foot Ulcer clinical trials

View clinical trials related to Diabetic Foot Ulcer.

Filter by:

NCT ID: NCT04959071 Completed - Diabetes Mellitus Clinical Trials

Mean Healing Time of Wound After Vacuum Assisted Closure (VAC) Versus Conventional Dressing in Diabetic Foot Ulcer Patients

Start date: February 28, 2020
Phase: N/A
Study type: Interventional

Comparison the mean healing time of wound after vacuum assisted closure(VAC) versus conventional dressing(CD) in diabetic foot ulcer(DFU) patients. DFUs are chronic wounds in diabetics resulting from ischemia, angiogenesis defects and impaired immunity. Different treatment modalities are available for treating DFUs. Amongst them VAC provides a new paradigm for diabetic wound dressing. Different studies concluded that DFUs treated with VAC are more likely to heal than CD. The average healing time varies greatly among different studies conducted. Therefore, we conducted this study to compare the mean healing time of wound after VAC and CD in DFU patients. Based on these results, the method with lesser healing time can be opted for our routine practice guidelines for DFU patient's management protocol.

NCT ID: NCT04918784 Completed - Diabetic Foot Ulcer Clinical Trials

Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers

Start date: May 5, 2021
Phase: N/A
Study type: Interventional

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 subjects.

NCT ID: NCT04817228 Completed - Diabetic Foot Ulcer Clinical Trials

A Study to Evaluate the Clinical Performance, Safety and Pharmacology Effect of EscharEx in Patients With Lower Leg Ulcers

Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

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). In addition, the pharmacology effect of EX-02 will be assessed. Lower leg ulcer size between 2 cm2 and 80 cm2 (surface area).

NCT ID: NCT04803708 Completed - Diabetic Foot Ulcer Clinical Trials

Bacteriophage Therapy TP-102 in Diabetic Foot Ulcers

REVERSE
Start date: March 22, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa trial designed to evaluate topical bacteriophage therapy in patients with diabetic foot ulcers.

NCT ID: NCT04769115 Completed - Diabetic Foot Ulcer Clinical Trials

A Predictive Technology for Prevention of Diabetic Foot Ulcers

Start date: February 24, 2021
Phase: N/A
Study type: Interventional

The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.

NCT ID: NCT04755647 Completed - Diabetic Foot Ulcer Clinical Trials

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers

Start date: February 23, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.

NCT ID: NCT04753294 Completed - Diabetic Foot Ulcer Clinical Trials

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

ASOLO-CW
Start date: June 14, 2021
Phase: N/A
Study type: Interventional

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

NCT ID: NCT04698720 Completed - Diabetes Mellitus Clinical Trials

Contribution of Psychological Factors in the Healing of the Diabetic Foot Ulcer

Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Research suggests that psychological factors may play an important role in DFU healing. Relaxation and hypnosis seem to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular chronic wounds such as DFU. This study will evaluate the efficacy of relaxation and hypnosis, both with guided imagery, in DFU healing, physiological indicators (inflammatory, metabolic, oxidative stress, angiogenic, and miRNA biomarkers) of wound healing prognosis, and QoL, in patients with diabetic foot and a chronic ulcer. This study is a Randomized Controlled Study of a Psychological Intervention that aims to evaluate the efficiency of a muscle relaxation intervention with guided imagery (experimental group - EG1) compare to a hypnosis intervention with guided imagery (experimental group - EG2) and a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG). This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation and hypnosis interventions, in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapys. Participants must have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic active ulcers at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the four conditions - EG1, EG2, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted independently with patients that completed the relaxation, hypnosis, and placebo sessions, and with the informal caregivers who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.

NCT ID: NCT04652999 Completed - Diabetes Mellitus Clinical Trials

Relaxation Intervention in Patients With Diabetic Foot Ulcer

Start date: March 19, 2019
Phase: N/A
Study type: Interventional

Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular on chronic wounds such as DFU. This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations. Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.

NCT ID: NCT04633642 Completed - Diabetic Foot Ulcer Clinical Trials

Ultrasound Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU)

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

The investigators aimed to elucidate the effects of UAW debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving outpatients with complicated diabetic foot ulcers that either received surgical debridement or UAW debridement every week during a six-week treatment period.