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Foot Ulcer clinical trials

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NCT ID: NCT04668755 Completed - Clinical trials for Charcot Joint of Foot

Effect of CROW 3d Printed Sole on Charcot Foot Ulcer

Start date: December 5, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the therapeutic effect of the Charcot Restraint Orthotic Walker three-dimensional printed sole on Charcot foot ulcer healing.

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.

NCT ID: NCT04624516 Completed - Diabetic Foot Ulcer Clinical Trials

Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence

Start date: September 4, 2019
Phase: N/A
Study type: Interventional

The incidence of diabetic foot ulcer recurrence in one year can reach 35%. Plantar foot diabetic foot ulcer is the most frequently diabetic foot ulcer recurrence. The recurrence incidence can occur at least 14 days after the diabetic foot ulcer has healed. Physical activity and exercise are highly recommended for the prevention of diabetic foot ulcers. The study about the form of foot exercise to prevent a diabetic foot ulcer recurrence is still unclear. The major hypothesis was there is an effect of self-structured foot exercise on the plantar foot diabetic ulcer recurrences. The minor hypothesis was (1) The improvement of HbA1c, ABI, diabetic neuropathy examination score, callus, and walking speed can decrease the incidence of plantar foot diabetic ulcer (2) a self-structured foot exercise can decrease the incidence and the speed of incidence plantar doot diabetic ulcer recurrence. Participants were randomized into two groups: Exercise group (n=25) and control group (n=25). The exercise is the combination of flexibility and resistance exercise using a flexible band in 24 weeks. The incidence of plantar diabetic foot ulcers was monitored through the research process.

NCT ID: NCT04593693 Completed - Diabetic Foot Ulcer Clinical Trials

A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.

NCT ID: NCT04590703 Completed - Diabetic Foot Ulcer Clinical Trials

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-301 Clinical Trial

Start date: June 24, 2020
Phase:
Study type: Observational

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-301) for 24 months

NCT ID: NCT04577183 Completed - Diabetic Foot Ulcer Clinical Trials

A Prospective, Open Label, Multicenter Trial for Evaluating the Efficacy of Treating and Managing Wounds in Elderly Population in Specialized Nursing Facilities Using RD1

Start date: July 11, 2018
Phase: N/A
Study type: Interventional

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 of these subjects). The subjects will receive up to 16 RD1 applications. In case of complete healing, subject will be called for one confirmatory visit two weeks later or before discharge from the SNF (the earlier of the two). Subject data will be kept in each site's records. All diabetic subjects' glycemic management will be performed by a qualified physician. All subjects will have wound care specialist or wound surgeon or dermatologist involved in their wound care

NCT ID: NCT04558775 Completed - Diabetes Clinical Trials

TEWL Biomarker Study for Diabetic Foot Ulcer Recurrence

TEWL
Start date: June 17, 2020
Phase:
Study type: Observational

This is a multicenter study of patients with diabetic foot ulcers (DFU) to develop and validate potential tissue-based biomarkers that predict DFU wound recurrence. Trans-epidermal water loss (TEWL) will be measured on the closed wound site and a location similar to the wound site (reference site). Participants will be enrolled within two weeks after closure of their DFU. Complete wound healing will be verified at a second visit two weeks later and this visit will start the 16 week timeline where participants will be followed weekly by phone until the earliest of DFU wound recurrence or 16 weeks. Participants who experience a DFU wound recurrence and a subset of participants who do not experience a DFU wound recurrence by week 16 will be asked to attend one final visit.

NCT ID: NCT04537520 Completed - Diabetes Clinical Trials

Interventional Clinical Trial Comparing Kerecis Omega3 Wound Versus SOC in Diabetic Foot Wounds

KereFish
Start date: July 2, 2020
Phase: N/A
Study type: Interventional

The KereFish study is a randomized controlled study to study the efficacy of Kerecis Omega3 Wound on deep diabetic ulcers. This study is probably the first in his field: in this one, the Kerecis Omega3 Wound dies are used on the types of wounds for which they are ultimately intended. This study aims to document the cost benefits of earlier closure of severe diabetic wounds, or the change of the deep and chronic wound into a smaller and shallower ulcer, and to radically alter its prognosis. The study, carried out in France, uses the pre-existing home nursing system with the transmission of photographs to the reference centre. The study was largely designed to ensure transparency of the financial calculations involved.

NCT ID: NCT04480801 Completed - Diabetic Foot Clinical Trials

The Effect of Thermal Evaluation in Prevention of Diabetic Foot Ulcer

Start date: September 15, 2020
Phase: N/A
Study type: Interventional

The study was planned as a prospective randomized controlled clinical trial to determine the effect of thermal evaluation in preventing diabetic foot ulcers in patients with Type II Diabetes Mellitus (DM).