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85 active trials for Diabetic Foot Ulcer

BB-101 for Treatment of Diabetic Lower Leg and Foot Ulcers

This is a randomized, double-blind, placebo-controlled, sequential dose escalation study in diabetic subjects with a diabetic lower leg or foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit.

Start: March 2018

Kerecis Omega3 Wound Plus SOC vs. SOC Alone in Treating Severe Diabetic Foot Ulcers and Forefoot Amputations

This is a prospective, multi-national, multi-centre, randomized, non-blinded (photo evaluation is blinded), controlled clinical investigation in patients suffering from diabetic wounds reaching to tendon, bone, or joint. Patients will be randomised to received intact fish skin (Kerecis™ Omega3 Wound) plus standard of care or standard of care alone, and wound healing compared over 16 weeks.

Start: July 2020

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

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.

Start: July 2020

Omega3 Wound Fish Skin Graft in the Treatment of DFUs

The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA-approved product that is derived from minimal processing of Atlantic cod fish skin: KerecisTM Omega3 Wound. In this trial, two groups of UT grade IA/1C diabetic foot ulcers (DFUs), full skin thickness or extending through the subcutaneous or fat layers but not into tendon, muscle, or bone will receive standard of care (SOC) treatment for their condition. Patients will be randomized to SOC treatment and a 510k FDA-approved collagen alginate dressing (Fibracol Plus) or SOC and KerecisTM Omega3 Wound. The primary endpoint is the percentage of index ulcers (the ulcers being treated in the study) healed at 12 weeks in which two groups that will be compared are SOC with Fibracol Plus or SOC with KerecisTM Omega3 Wound

Start: July 2019

Enhanced Ultrasound Treatment of Chronic Wounds With Monitoring of Healing and Quality of Life Outcomes

The purpose of this study is to evaluate the effect of low frequency, low intensity ultrasound treatment on wound healing and health-related quality of life with a randomized clinical trial of patients with venous ulcers or diabetic ulcers.

Start: January 2017

Offloading Interventions for Diabetic Foot Problems in Upper Egypt

Offloading is the concept of relieving pressure to help prevent/cure plantar ulcers, especially in diabetic patients. Many forms of offloading are available, with many limitations to apply in clinical practice. In this study, the investigators compare cast shoe with removable walker considering effectiveness, complications, compliance and patient's appreciation.

Start: February 2019

Vibration Enhances Diabetic ULCER Healing

Objectives: Diabetes has a prevalence of 11.6% in China with diabetic foot ulcerations affecting over 30 million Chinese. 85% of these patients require amputation and 5-year mortality for diabetics is 70% when associated foot ulcers. Clinical trials have shown that standing on whole-body vibration platforms, specifically low-magnitude high-frequency vibration (LMHFV); promotes angiogenesis, enhances muscle bulk and accelerates epithelization. Investigation on diabetic rats with foot wounds found accelerated wound healing, increased perfusion and upregulation of factors such as VEGF, PECAM-1 and PCNA. Hypothesis: The investigators postulate LMHFV will enhance diabetic foot ulcer healing. Design and Subjects: Prospective, single-centre, randomised control trial to treat 106 subjects with diabetic foot ulcers. Interventions: The intervention group will stand on LMHFV whole-body vibration platforms for 20min on alternate days for 20 weeks, together with conventional dressing by a trained wound-care nurse as in the control group. Main Outcome Measures: Ulcer size will be measured at multiple time points, the incidence of amputations/infections will be recorded, perfusion via ankle-brachial pressure index will be calculated and foot function via the foot and ankle outcome score will be analysed. Data analysis: Repeated measure of ANOVA to analyze time-point differences and student's t-test for same time-point comparison. Expected Results: This is the first clinical trial to investigate the effect of whole-body vibration on diabetic foot ulcers. It will show the investigators if the results from animal studies will translate into clinically significant results. If positive effects are established, whole-body vibration can be a valuable treatment regime to tackle diabetic foot ulcers.

Start: September 2020

Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers

To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers

Start: August 2020

Characterization of AmnioExcel Plus in Two Treatment Paradigms

The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.

Start: July 2020

Pilot Study of PHOENIX Impact on Wound Microbiome

A Pilot Study to Determine the Impact of the Phoenix Wound Matrix® on the Wound Microbiome in Chronic Diabetic Foot Ulcers

Start: August 2020

Debritom - Micro Water Jet Technology and Wound Healing

This study will investigate the clinical efficacy of micro water jet technology in the debridement and healing of chronic lower extremity ulcers.

Start: January 2020

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

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.

Start: March 2020

The Effect of Exercise on Wound Healing While Off-loading

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.

Start: March 2020

High Intensity LED Photobiomodulation Therapy for Chronic Leg and Foot Ulcers

Diabetic and venous ulcers affect many people, and severe cases can end up in amputation and even death because of infection. In 2011, the total cost for care of diabetic foot ulcers alone, to the Canadian health care system, was $547 million. Standard clinical care for these types of wounds has improved but there is still a great need for new wound care treatments to help speed up wound healing and reduce pain. One such treatment is high intensity LED light therapy. There is a long history of light therapy showing faster wound healing, reduced pain and reduced swelling. The research we propose here is to study a new high intensity LED light made by Kerber Applied Research Inc., to see if it reduces pain and speeds up healing lower leg ulcers. This research is a partnership between Kerber Applied Research Inc and the Lethbridge Lower Limb Wound Clinic, an Alberta Health Services program in Lethbridge, Alberta.

Start: February 2020

Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers

Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.

Start: August 2019

Effectiveness of Vaporous Hyperoxia Therapy (VHT) in the Treatment of Chronic Diabetic Foot Ulcers

The purpose of this study is to evaluate the effectiveness of Vaporous Hyperoxia Therapy (VHT) for the treatment of Diabetic Foot Ulcers.

Start: June 2019

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

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.

Start: November 2019

Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers

Diabetic foot ulcer (DFU) is a common complication of diabetes with global prevalence of 6.3%. Treatment of diabetic foot ulcer (DFU) is challenging with disappointing outcome. Wound debridement, infection control, pressure relief and revascularization are main pillars of DFU management. Various substances and modalities are being investigated for their potential effects in treating DFU, one of which is LL-37. In this randomized, controlled trial, 40 patients with uncomplicated DFU will be enrolled. Patients are randomly assigned to undergo twice a week treatment with 0.5 mg/mL LL-37 cream (treatment group) or placebo cream (control group) for 4 weeks in addition to standard wound care. The primary outcomes are the healing rate measured by wound area and granulation index and changes in patterns of aerobic bacteria colonization during the 4-week study duration and changes in concentrations of IL-? and TNF-? from fluid collected from DFU on the end of the second and third week of study compared to baseline.

Start: October 2019

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

Role of Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers • The aim of this study will be to assess negative pressure wound therapy in treating diabetic foot ulcers.

Start: November 2019

Diabetes Foot Care Clinical Pathway - Orpyx Medical Technologies

In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as one of three significant targets for pan-provincial action. The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce lower limb amputation (LLA) by 50%. The DFCCPP key deliverables apply consistency in assessment, care, treatment and process standards, early intervention and complex wound care management, while optimizing health outcomes. To achieve these deliverables, High Risk Foot Teams (HRFTs) will be implemented across the province starting with three pilot sites (Slave Lake, Brooks, and outpatient clinics at the Peter Lougheed Hospital). The pilot site facilities were selected on the basis of their employing staff with expertise and knowledge in diabetic foot care. The HRFT will assess and treat patients with moderate and high-risk findings, and this care pathway will then be rolled out to all clinicians who perform diabetic foot assessments (Primary Care, Home Care, Diabetes Centers, First Nations Reserves, etc.). In conjunction with the DFCCPP, we will evaluate the efficacy of a technological device developed by Alberta-based small-medium enterprise (SME) to improve diabetic foot outcomes by preventing future wounds in high-risk patients who have recently been treated for active foot ulcers. This technology is the SurroSense Rx® smart insole system (Orpyx Medical Technologies Inc., Calgary AB), a device that provides dynamic offloading guidance to patients, in addition to enabling ongoing adherence tracking by the HRFT. It is hypothesized that early wound detection and treatment will ultimately lead to improvements in wound prevalence, chronic wound care, and reduce the need for surgical intervention, including LLA.

Start: November 2016