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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT05551988 Completed - Diabetic Foot Ulcer Clinical Trials

Predictors of Foot Amputation in Diabetic Foot Ulcers

Start date: June 1, 2021
Phase:
Study type: Observational

Diabetes affects 463 million population of the world. Diabetic foot is one of the complications of uncontrolled diabetes which can lead to amputation in 5- 24% of non-healing diabetic foot ulcers. Every 30 seconds a lower extremity is amputated in the world due to diabetes. This is a retrospective study conducted in Balochistan, Pakistan. In this study investigators explored the risk factor of amputation in diabetic patients. Baseline characteristics, clinical profile, and lab tests were retrieved retrospectively and presented in the forms of tables. Investigators compared the categorical variables in amputees vs non-amputees and analyzed associated risk factors of amputation.

NCT ID: NCT05422846 Completed - Diabetic Foot Ulcer Clinical Trials

Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Exercise studies with patients with diabetic foot ulcers are very few. In this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. With the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. Among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.

NCT ID: NCT05324930 Completed - Diabetic Foot Ulcer Clinical Trials

Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients

Start date: December 2, 2021
Phase: N/A
Study type: Interventional

Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and require advanced wound care. Piscean collagen has the potential to promote the regenerative process while remaining cost-effective and with minimal side effects. In this study, the efficacy of a piscean collagen matrix dressing was compared with a standard dressing of saline-moistened gauze for wound healing in patients with neuropathic DFU. This is a double-blinded, randomised clinical trial.

NCT ID: NCT05243810 Completed - Diabetic Foot Ulcer Clinical Trials

EPC Silver Wound Gel (EPC-123) Feasibility Study in the Management of Mildly Infected Diabetic Foot Ulcers

Start date: November 28, 2022
Phase: N/A
Study type: Interventional

The objective of this single-arm feasibility study is to investigate the safety and impact of the topical EPC Silver Wound Gel (EPC-123) in the management of diabetic foot ulcer wounds not progressing under the current standard of care.

NCT ID: NCT05215730 Completed - Diabetic Foot Ulcer Clinical Trials

Comparison of Wound Healing Between MedCu Dressings With Copper Oxide and Negative Pressure Wound Therapy Treatment

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

Randomized multisite two arms study in which one arm of patients will be treated with Negative Pressure Wound Therapy (NPWT) known also as Vacuum-assisted closure (VAC) treatment ("VAC Arm") and the second arm of patients will be treated with MedCu wound dressings with copper oxide (COD) ("Copper Arm"). The study goals are to compare the efficacy, cost and convenience between MedCu Wound Dressings with Copper Oxide (COD) and Negative Pressure Wound Therapy of diabetic foot wounds.

NCT ID: NCT05148390 Completed - Diabetic Foot Ulcer Clinical Trials

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

GELFI
Start date: April 24, 2022
Phase:
Study type: Observational

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

NCT ID: NCT05145439 Completed - Clinical trials for Peripheral Arterial Disease

A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.

Dulcet
Start date: January 14, 2023
Phase: N/A
Study type: Interventional

This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).

NCT ID: NCT05101473 Completed - Diabetic Foot Ulcer Clinical Trials

Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT. The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.

NCT ID: NCT05071235 Completed - Diabetic Foot Ulcer Clinical Trials

Quality of Life and Self-care in Patients With Diabetic Foot Ulcers Treated With Low-level Laser Therapy

Start date: August 27, 2019
Phase: N/A
Study type: Interventional

Diabetic foot ulcers (DFU) are aggressive complications of diabetes mellitus (DM) and affect 25% of these patients. DFU are associated with a high risk of amputations and early mortality and significantly impact quality of life (QoL). The low-level laser therapy (LLLT) is an important approach for the treatment of DFU, however there is a lack of data on its influence on the QoL of patients with DFU. On the other hand, adherence to self-care is a factor closely related to QoL. Therefore, this study is justified by the need to understand the impact of LLLT on QoL and its relationship with self-care. Aim: To evaluate the quality of life of patients with diabetic foot ulcers treated with different doses of LLLT (GaAs) 904 nm and its association with aspects of adherence to self-care. Methods: This is a randomized, double-blind, placebo-controlled clinical trial. Participants will be randomly assigned to the groups: control LLLT placebo (CG), LLLT 904 nm 10 J/cm² (LG1), LLLT 904 nm 8 J/cm² (LG2) and LLLT 904 nm 4 J/cm² (LG3). QoL data, percentage of healing and pain will be assessed before the start of the intervention, in 10th week and after one month to the end of intervention, self-care will be assessed before the start of the intervention and at the end of intervention. Eighty participants with DFU will be recruited who will receive intervention twice a week for up to 20 visits (10 weeks).

NCT ID: NCT05039645 Completed - Diabetic Foot Ulcer Clinical Trials

Use of Remote Thermovisual Monitoring in Patients With a Previous Diabetic Foot Ulcer

Start date: March 31, 2022
Phase: N/A
Study type: Interventional

The goal of the clinical trial is to investigate adherence to, and effects of, the Bluedrop Monitoring System (BMS) in high-risk patients with at least one previous diabetic foot ulcer (DFU). The BMS is a remote thermovisual monitoring system, which allows the condition of the soles of the feet to be remotely monitored for thermal and visual signs of inflammation, both of which may signal the onset of certain conditions, such as diabetic foot ulcers. It is comprised of the Delta Foot Scanner (DFS) device and its accompanying Sentinel Review Interface (SRI) software. The Covid-19 pandemic has driven the need for remote patient care where possible. Although this is challenging for people with foot ulcers, prevention is the key. Remote thermovisual monitoring might help reduce recurrent foot ulcers and therefore the number of necessary hospital visits which always puts the patient at increased risk of Covid infection.