A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating...
Diabetic Foot UlcersDiabetesA Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment. Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.
Effectiveness of Aurix Therapy in Diabetic Foot Ulcers
Diabetic Foot UlcersThe aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, randomized trial in which diabetic food ulcers (DFU) will be treated using Aurix plus Usual and Customary Care (UCC) and compared to a group receiving just UCC as provided in up to 100 U.S. wound centers
Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic...
Diabetic Foot Ulcer(s)The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.
Randomized, Prospective Evaluation of the Toad Brace in Plantar Ulcer Off-loading and Healing
Diabetic FootPedal UlcersThe TOAD Medical Corporation Brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. This trial will attempt to show the efficacy of the Toad Brace and is based on the hypothesis that the Toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. The trial will randomize 74 patients with diabetic pedal ulcers to the Toad Brace or conventional therapy. . Quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. The pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. The trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the Toad Brace.
A Comparison of the dermaPACE® (Pulsed Acoustic Cellular Expression) Device in Conjunction With...
Diabetic Foot UlcersThe Sponsor of this study, SANUWAVE, Inc., has developed an investigational device known as the dermaPACE® (Pulsed Acoustic Cellular Expression) device for the possible treatment of diabetic foot ulcers. This device generates acoustic (sound) pressure waves designed to act on the cells in your body to generate proteins that may lead to wound closure. The dermaPACE® device has not been approved for the treatment of diabetic foot ulcers; therefore its use in this study is investigational. The purpose of the study is to evaluate the ability of the dermaPACE® device to help diabetic foot ulcers heal more quickly. The active study device, the dermaPACE®, will be compared to an inactive look-alike device (called a "Sham") in this study. The sham device will not provide any treatment to your diabetic foot ulcer.
The Use of Allogenic Platelet Rich Plasma for the Treatment of Diabetic Foot Ulcer
Diabetic Foot UlcerAllogenic defibrinated platelet rich plasma lysate will be injected in patients diagnosed with Diabetic Foot Ulcer (DFU).
Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot
Diabetes Mellitus Foot UlcerProgram Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells Bidding Unit: Tenth People's Hospital Affiliated to Tongji University Study subjects: diabetic foot patients OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy. Study Design: Randomized Controlled Clinical Study Target number of cases: 60 Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group. Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)
Study of Combined Topical Growth Factor and Protease Inhibitor in Chronic Wound Healing
Venous UlcerFoot Ulcer1 moreLeg and foot ulcers due to venous disease or diabetes are chronic wounds that can take 6 or more months to heal. Growth factors have been used to try and improve this healing, however, many such studies have failed, and that is thought to be due enzymes in the wound that degrade the growth factors and prevent them from working. This is a proof of concept study that will evaluate the treatment of chronic leg ulcers with topically applied growth factors that are combined with a therapy to prevent their inactivation in the wound.
Dipeptidyl Peptidase 4 Inhibition Facilitate Healing of Diabetic Ulcers
Diabetic Foot UlcerTo investigate the effect of Dipeptidyl Peptidase 4 Inhibition on wound healing in patients with diabetic foot ulcers, the investigators randomly divided the participants into two groups: saxagliptin with regular treatment group,placebo with regular treatment group. The clinical data are collected at the given time point. This study aimed to observe the potential protective effect of DPP4i on diabetic ulcers.
Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy...
Diabetic Foot UlcerDiabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. The purpose of this study is to evaluate the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care providers treating high-risk patients with DFUs regardless if secondary fungal infections are present. Participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot ulcer/wound with or without a secondary fungal infection will be included in this prospective, active intervention pilot study. Healing rates will be evaluated every two weeks following the initiation of study therapy up to three months. Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. Participants will be asked to return to clinic every two - four weeks for assessment of the ulcer and compliance with treatment. A sample size of approximately 100 patients is estimated to have 90% power to detect 15% improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of approximately 30% for ulcers of <6 months duration and 20% for ulcers ≥6 months duration and/or prior treatment failure, respectively.