Clinical Research Directory

Amnio-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers

Derm-Maxx in Patients With Diabetic Foot Ulcers Unresponsive to Standard of Care Treatment Alone

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers

The goal of this multi-center, randomized, controlled, evaluator-blinded study is to assess and measure the safety and efficacy of NOX1416 as an adjunct to standard of care (SOC) in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 as an adjunct to Standard of Care (SOC) or SOC alone. The primary objective of the study is to demonstrate the safety and tolerability of NOX1416 as adjunct to SOC. The secondary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to SOC, in the treatment of chronic, non-healing diabetic foot ulcers. The study will use a centralized blinded assessor. The blinded assessor will be responsible for assessing the efficacy endpoints such as wound measurements and complete wound closure. The blinded assessor will not be involved in the clinical care of the subject.

Randomized Evaluation of Nonhealing Diabetic Foot Ulcers With Exclusive Wound Therapy

The goal of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers with multiple CAMPs plus SOC versus matched controls over 12 weeks using a modified platform trial design.

WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention

The primary aim of this study is to demonstrate the impact of the Orpyx® Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications. The secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.

Effect of Virtual Reality on Pain, Anxiety and Vital Signs During Diabetic Foot Care

This study aims to determine the effects of a virtual reality (VR) intervention on pain level, state anxiety, and vital signs during foot care in individuals with diabetic foot ulcers. The study was designed as a randomized controlled trial and includes 64 individuals with diabetes (intervention=32, control=32). The intervention group will receive VR during diabetic foot care, while the control group will receive standard care. Data will be collected at pre-test and post-test using the Demographic Information Form, Vital Signs Form, State-Trait Anxiety Inventory (STAI), and Visual Analog Scale (VAS) for pain. Data analysis will be performed using SPSS 22.0.

Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers

This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.

Orthotic Treatment of Diabetic Foot Ulcers

The United States Department of Veterans Affairs spends an estimated $1.5 billion a year on healthcare for patients with diabetes. The prevalence and complications of diabetes increase with age. Therefore, with the aging of the US and Veteran populations, there is an expectation of increased healthcare costs associated with treating diabetes and the associated complications of this disorder. One common complication is the diabetic foot ulcer. Diabetic foot ulcers are expensive to treat, can take a long time to heal and result in a decrease in patient quality of life. Patients remain susceptible to developing more foot ulcers over time. The goal of this project is to reduce the time it takes to heal a diabetic foot ulcer, increase the time between episodes of ulceration and improve the quality of life for diabetic foot ulcer patients.

Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs). The main questions it aims to answer are: * Will there be a difference in the number of major amputations between the groups during the first year? * Will one of the treatments require more surgeries and longer hospital stays? All participants will: * be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery * be followed closely at the out-patient clinic for one year after treatment

Transverse Tibial Bone Transport (TTT) in the Management of Chronic Diabetic Lower Extremity Wounds

The purpose of this study is to evaluate the safety and clinical performance of transverse tibial bone transport in patients with chronic ischemic and diabetic lower extremity ulcers. This study will assess wound healing outcomes and limb preservation in a population with limited therapeutic alternatives.

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

This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.

At-Home Exercise Study for Veterans With Healed Diabetic Foot Ulcers

Foot ulcers and amputations are a common and feared complication for people with diabetes. People with a diabetic foot ulcer have a higher risk of dying within five years than people with diabetes without an ulcer. At least one in four people with a new diabetic foot ulcer will die within five years, largely due to cardiovascular causes. The reasons for this increased mortality involve decreased mobility. People with a recently healed diabetic foot ulcer are considered "in remission" as opposed to "cured" because the underlying medical problems which led to their ulcer are still present. Once in remission, the current standard of care is to slowly increase ambulation. The problem is that people rarely return to the recommended level of mobility. The ability to safely maintain mobility with aging is critical. This pilot study is a small clinical trial to test the feasibility and acceptability of a home-based exercise regimen. The investigators will also assess if this home-based exercise regimen can increase mobility and function without increasing diabetic foot ulcer recurrence by improving lower extremity strength, lower extremity tissue perfusion and glycemic control.

Subcutaneous Dexpanthenol Administration and Wound Epithelialization

Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers. Improving wound healing and speeding up skin regeneration (epithelialization) are important goals in the care of these patients. Dexpanthenol is a vitamin B5 derivative that supports skin repair and tissue regeneration. It is widely used in topical treatments, and injectable forms are approved for clinical use. However, the effects of subcutaneous (under the skin) dexpanthenol injections on chronic wound healing have not been sufficiently studied in clinical settings. The purpose of this study is to evaluate whether adding subcutaneous dexpanthenol injections to standard wound care improves wound healing compared with standard wound care alone. Adult patients with non-infected chronic wounds will be randomly assigned to one of two groups. One group will receive standard wound care only, while the other group will receive standard wound care plus subcutaneous dexpanthenol injections around the wound area. Wound healing will be assessed by measuring changes in wound size and the degree of skin epithelialization over time using standardized and objective methods. Safety will be monitored by recording local reactions at the injection site and any other adverse events during the study. The results of this study may provide preliminary clinical evidence on the effectiveness and safety of subcutaneous dexpanthenol as an additional treatment option for chronic wound management.

A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of hard-to-heal diabetic foot and venous leg ulcers.

Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers

The purpose of this study is to determine how well multiple CAMPs (Cellular, Acellular and Matrix-Like Products) and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers.

Study Assessing Complete Wound Healing by Comparing Surgenex® PelloGraft in Treating DFU and SanoGraft® in Treating VLU to SOC

The purpose of this study is to compare Pellograft to standard of care modalities in treating diabetic foot ulcers in human subjects, and to compare Sanograft to standard of care in treating venous leg ulcers. The study will demonstrate wound healing outcomes with comparators including time to wound epithelialization, decrease in wound size, and total number of study product applications towards healing outcome. This information is important to the Centers for Medicare and Medicaid Services (CMS) and other payors in determining coverage policy and reimbursement for this product category.

Tele-Exercise Platform for Plantar Wound Healing

The purpose of the study is design and use a telemedicine platform which integrates video-chat, pre-programmed interactive game-based foot, and ankle exercise modules, and real-time quantitative performance metrics displayed to the clinician to improve patient's perfusion to the lower extremity, improve diabetic wound healing and prevent muscle loss in the lower extremity.This is a cross sectional and comparative feasibility study. It is designed to explore acceptability, feasibility and proof of concept/ .

Evaluating the Efficacy of Pulsating Electromagnetic Field Therapy by CRAD ULCER X-01 for Diabetic Foot Ulcers

Background: Diabetic foot ulcer (DFU) is a frequent complication of chronic, uncontrolled diabetes mellitus (DM). Treatment with antibiotics, daily dressing, wound debridement, and wound off-loading is often prescribed. However, many DFU patients still progress into severe outcomes, including non-healing of wounds, infections, necrosis, and osteomyelitis. Prior research has shown that the application of pulsating electromagnetic field (PEMF) could accelerate wound healing, including in those afflicted with DFUs. Therefore, this study aimed to evaluate the efficacy of a locally developed CRAD ULCER X-01 device that uses the principles of PEMF in promoting DFU healing. Methods: A total of 32 patients with chronic, non-healing DFUs will be recruited from the Orthopaedic Clinic of Hospital Angkatan Tentera Tuanku Mizan and divided into control (C) (n=8) and treatment (T) (n=24) groups. All patients will receive a standard daily dressing. The PEMF will be supplemented for 1 hour/day, 2 hours/day, and 3 hours/day for T1, T2, and T3 subgroups, respectively (n=8 per group); whereas the C group will be controlled for placebo effect (device in-place but switched off). The therapy duration will be until the wound is closed or for a maximum period of three months. All patients will undergo wound assessment, wound edge tissue histology by haematoxylin and eosin (H\&E) staining, and immunohistology (for vascular endothelial growth factor \[VEGF\] and fibroblast growth factor 2 \[FGF-2\] expression), as well as serum superoxide dismutase (SOD) and C-reactive protein (CRP) at preand post-treatment, along with glycated haemoglobin (HbA1c) measurement only at post-treatment to control for confounder (i.e., glucose control for the past three months). This study hypothesizes that PEMF therapy by CRAD ULCER X-01 device will accelerate DFU healing and improve tissue integrity, with minimal systemic effects assessed via oxidative stress and inflammatory markers. Conclusion: The results from this study will validate PEMF's effectiveness in promoting DFU healing and establish the potential use of locally developed CRAD ULCER X-01 devices as supplementary therapy to standard DFU care.

Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Diabetic Foot Ulcers

This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Diabetic Foot Ulcers

Effect of Monochromatic Infrared Energy on Healing of Diabetic Foot Ulcers

The purpose of this study is to evaluate the effectiveness of monochromatic infrared energy (MIRE) as an adjunctive therapy for the healing of diabetic foot ulcers (DFUs).

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

Using Lymphovenous Bypass to Alleviate Diabetic Peripheral Neuropathy

Diabetes is a metabolic disease characterized by high blood sugar levels due to a lack of insulin. Long-term metabolic disorders can cause structural and functional changes in many organs, mainly affecting the vascular system, and leading to complications in the eyes, kidneys, and nervous system. Diabetic Peripheral Neuropathy (DPN) is a common complication, affecting about 50% of patients. According to the Chinese Diabetes Association, DPN is diagnosed when diabetic patients exhibit signs of peripheral nerve dysfunction, as determined by physical examination or electrophysiological testing, after excluding other causes. The prevalence of DPN in diabetic patients is generally over 30%, with 20-30% experiencing significant pain and mobility issues, severely affecting quality of life and increasing the risk of amputation. Prevention and control rely on strict blood sugar management and lifestyle adjustments, as no medication or surgical intervention can cure DPN. The lymphatic system plays an immunological role in regulating immune cell migration and inflammatory responses. Supermicrosurgical lymphovenous bypass (LVB) has become a routine treatment for lymphedema, allowing high-pressure lymph fluid to drain into non-occluded deep venous systems, alleviating lymphedema, restoring TH1 and TH2 balance, reducing oxidative stress, and enhancing antioxidant capacity. LVB may delay DPN progression, alleviate pain (DPNP), and promote diabetic foot ulcer healing. In our clinical experience, a patient with Charcot's neuroarthropathy and chronic plantar ulcers underwent LVB alongside wound care. Five years of follow-up showed complete wound healing without further amputation, despite poor HbA1c control. Thus, we aim to further accumulate clinical experience and data, study histological changes, and confirm the benefits of this surgery to help similar patients.

Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers

ELU42 01 01 (SuperHealer42) is a Phase I/IIA open label study sponsored by Eluciderm, Inc. that evaluates the safety and preliminary effectiveness of ELU42, a topical small molecule designed to modulate Wnt signaling, for the treatment of chronic diabetic foot ulcers (DFU). ELU42 combines a tankyrase inhibitor (XAV939) with a novel derivatized hyaluronic acid excipient (DHA77) and is applied as a topical spray to the index ulcer. Fifteen adults with Wagner grade 1-2 diabetic foot ulcers that have been present for at least 4 weeks and up to 52 weeks will be enrolled across up to four U.S. clinical sites. After a 2 week run in period during which standard of care (SOC) is provided (off loading, dressings, and debridement), subjects will receive ELU42 applied on site by trained study staff or the investigator three times per week (Monday, Wednesday, Friday) for six weeks (up to 18 applications). Subjects will be followed weekly during treatment and for up to 6 weeks after the final dose; additional Healing Confirmation visits are scheduled if the wound closes to evaluate the subjects over a course of a 3 month period. The study's co-primary objectives are to assess safety (incidence and severity of adverse events and infections) and to measure percent area reduction (PAR) of the index ulcer at Weeks 4 and 6. Efficacy assessments will be performed by the site investigator using direct two axis planimetry and by automated evaluation using the Tissue Analytics platform (surface area, volume, and PAR). Secondary and exploratory assessments include patient reported outcomes (Wound Q and SF 36), frequency of complete wound healing, wound hydration metrics, and pharmacokinetic sampling in a subset of subjects. Contact information for potential participants and referring clinicians is available at each participating site.

A Multicenter, Prospective, Controlled Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers

A multicenter, prospective, controlled clinical trial evaluating the efficacy of a single layer placental-based allograft and standard of care in the management of nonhealing diabetic foot ulcers.