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Diabetic Foot Ulcer clinical trials

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NCT ID: NCT04323462 Recruiting - Diabetic Foot Ulcer Clinical Trials

Intensive Glycemic Control For Diabetic Foot Ulcer Healing

INGLOBE
Start date: October 1, 2021
Phase: Phase 4
Study type: Interventional

With the available molecular and cellular evidence of impaired wound healing due to hyperglycemia, investigators postulate hypothesis asking whether intensive glycemic control could improve diabetic foot ulcer healing rates. A study showed improvement in phagocytic activity of macrophages after 5 days of intensive glycemic improvement in 21 patients of diabetes. Another retrospective cohort study studied the effect on HbA1c as predictor of healing rate in DFU. Latter found significant association of HbA1c with wound area healing rate. However a recent systematic review failed to find any randomized control trial comparing the effect of intensive versus conventional glycemic control for treating DFU. Hence, investigators want to explore the hypothesis by conducting a randomized control trial with the primary aim of wound healing in patients of diabetic foot ulcer in response to intensive glycemic control in comparison to conventional glycemic management.

NCT ID: NCT04310137 Recruiting - Diabetic Foot Ulcer Clinical Trials

Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence

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

This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.

NCT ID: NCT04280016 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Effect of Exercise on Wound Healing While Off-loading

Start date: May 14, 2021
Phase: N/A
Study type: Interventional

This study seeks to establish the effect of adding exercise to off-loading interventions on the healing time for people with diabetes mellitus and a foot ulcer. Hypothesis: Consistent with the literature, results are expected to resemble the accelerated healing seen when older adults exercised in the presence of wounds.

NCT ID: NCT04232631 Recruiting - Diabetic Foot Ulcer Clinical Trials

Non-Invasive Testing to Evaluate Wound Healing in Diabetes

Start date: April 28, 2021
Phase:
Study type: Observational

Data will be collected with 3 vascular imaging devices (IntraOx Vioptix, Newark, CA; Hyperview, HyperMed Imaging, Memphis, TN; Snapshot NIH, Kent Imaging, Calgary, Alberta, Canada). The wound will be imaged with the 3 devices at index research encounter (this will count as the initial pre-operative imaging if the patient requires surgery), before surgery for interval or additional surgeries, during surgery, and during clinic follow-up (one set of imaging approximately every 3-5 weeks) visits for a maximum follow up time of 12 months or until the wound is documented as healed, whichever occurs first. The investigators will collect data from the medial and lateral angiosomes on the dorsum and plantar aspects of the foot and the anterior and posterior leg. Subject data will be obtained from the patient by oral history and physical exam and the medical records of patients of the investigators: vascular data, demographic medical history, wound characteristics and measurements, frequency of debridement and off-loading. Collection of lab data will be obtained such as cultures glycosylated hemoglobin, hemoglobin and hematocrit, ESR, CRP and eGFR obtained per standard of care. Imaging with the three devices is research-only and is not standard of care.

NCT ID: NCT04210089 Recruiting - Diabetes Mellitus Clinical Trials

Total Contact Soft Cast in Diabetic Foot Ulcers

Start date: October 13, 2020
Phase: N/A
Study type: Interventional

To determine the effectiveness, compliance, patient tolerance, ease of use and safety of total contact soft cast in diabetic foot ulcers.

NCT ID: NCT04198441 Recruiting - Diabetic Foot Ulcer Clinical Trials

The Omeza Protocol for Chronic Ulcers

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

This study will compare the Omeza® Products Bundle to standard of care (SOC) for in subjects with chronic venous leg ulcers and subjects with diabetic foot ulcers.

NCT ID: NCT04164641 Recruiting - Diabetic Foot Ulcer Clinical Trials

Noraxon myoRESEARCHâ„¢ Software Gait Analysis Evaluation and Orthotic Gait Correction in Reducing Diabetic Foot Ulceration Or Subsequent Amputation in Patients With a History of a Diabetic Foot Ulceration

NECRO
Start date: December 9, 2019
Phase: N/A
Study type: Interventional

Determining whether the utilization of Noraxon myoRESEARCH Software gait analysis Evaluation and orthotic gait Correction can reduce diabetic foot ulceration Or subsequent amputation in patients with a history of a diabetic foot ulceration.

NCT ID: NCT04117269 Recruiting - Diabetic Foot Ulcer Clinical Trials

External Shoe Lift to Improve Healing and Adherence in Patients With Diabetic Foot Ulcers

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Previous researches hipothesize that imposed limb-length discrepancies may discourage adherence in patients with active diabetic foot ulcer and using offloading devices. Our hipothesis is that the use of an external shoe lift contralaterally to the affected foot may improve adherence to offloading devices and improve healing.

NCT ID: NCT04058639 Recruiting - Diabetic Foot Ulcer Clinical Trials

Diabetic Foot Ulcers: Shorter Treatment Period Using Custom Felt Relief?

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

The Surgical Outpatient Clinic at Molde Hospital has since 2015 offered specialized treatment for patients with diabetic foot ulcers. This treatment is given by an interdisciplinary diabetic foot ulcer team. The standard treatment for diabetic foot ulcers is relief, a method with good results. Although the treatment as usual gives good results, the team wants to optimize this treatment. By using custom felt relief for each patient, the treatment period might be reduced considerably. The aim of this study is therefore to investigate whether custom felt relief gives shorter processing time compared to standard relief treatment.

NCT ID: NCT03960255 Recruiting - Diabetic Foot Ulcer Clinical Trials

Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers

Start date: February 20, 2021
Phase:
Study type: Observational

Diabetic foot ulcers (DFUs) and their associated complications like amputations are increasingly becoming a problem in low and middle income (LMI) countries. Obesity (increased body fat/adiposity), which has been shown to complicate many diseases, is also increasing in LMI setting. It is however not certain whether increased adiposity, may make it difficult for DFUs to heal. Investigators aim to understand whether increased adiposity and accompanied local microbial factors have any negative impact on healing and progression of DFUs.