Phase 3 N=116 Bosentan in Digital Ulcers
Digital Ulcers
Primary: Time to Complete Healing of Each Baseline DU
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Phase 2 N=17 Riociguat in Scleroderma Associated Digital Ulcers
Scleroderma · Digital Ulcers
Primary: Change From Baseline to End of Double-blind Treatment (Week 16) in Digital Ulcer Net Burden — -1.22; -0.98 ulcers — p=0.70
Phase 2 N=148 Digital Ischemic Lesions in Scleroderma Treated With Oral Treprostinil Diethanolamine
Systemic Sclerosis · Scleroderma
Primary: Net Ulcer Burden — 1.0; 2.0; 0.0; -1.0 ulcers — p=0.20
Phase 3 N=289 Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
Systemic Sclerosis · Ulcers
Primary: Incidence Rate of New Digital Ulcers (DUs) up to Week 16 — 0.9082; 0.9567; 0.8115 number of new DUs/observation days — p=0.706
N/A N=20 A Study to Evaluate the Efficacy of an Oral Medication in the Treatment and Prevention of Digital Ulcers in Patients With Systemic Sclerosis (Scleroderma).
n Ulcer · Scleroderma, Systemic
Primary: New Digital Ulcers (DU) 4 Weeks Prior to Week 24 — 0.06 new digital ulcers
Phase 3 N=68 Efficacy of the Combination of Isosorbide Dinitrate Spray and Chitosan in Diabetic Foot Ulcers
Diabetic Foot Ulcers
Primary: Biopsies — 2.46; 2.64; 2.56; 2.07 UI/dL
N/A N=12 A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.
Diabetic Foot Ulcer · Peripheral Arterial Disease · Wound; Foot
Primary: Transcutaneous Oxygen Pressure (TcPO2) — 50.96 mmHg
Phase 3 N=41 Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Scleroderma, Systemic · Scleroderma, Diffuse · Scleroderma, Limited
Primary: Digital Skin Microvascular Blood Flow Measured by Laser Doppler Imaging (LDI) Before Cold Stimulus — 260.0; 246.3 perfusion units
Phase 2 N=12 Systemic Sclerosis (SSc) Vasculopathy: Improved Clinical Monitoring and Treatment
Rheumatologic Disease
Primary: Flow Mediated Dilatation (FMD)-Diameter of Artery — 3.79; 3.78 mm
Phase 2 N=12 Safety and Efficacy of Oral Treprostinil in the Treatment of Calcinosis in Patients With Systemic Sclerosis
Systemic Sclerosis · Calcinosis
Primary: Number of Participants With Treatment-related Adverse Events Following Treatment With Oral Treprostinil — 11 Participants
N/A N=90 Blu Light for Ulcers Reduction
Leg Ulcers Venous · Dehiscence, Surgical Wound
Primary: Size of Wound Remaining Compared to Initial Wound Size — 42.58; 53.78 percentage of the remaining area
Phase 3 N=251 Low Dose Aspirin for Venous Leg Ulcers
Venous Leg Ulcer
Primary: Time to Complete Healing of Reference Ulcer — 77; 69 days — p=0.246
N/A N=8 ULCERS - Electrical Stimulation in Diabetic Foot Ulceration
Diabetes
Primary: Number of Day Until 50% Healing of Leg Ulcer — 55; 30 Days
Phase 4 N=106 DPP IV Inhibition Facilitates Healing of Chronic Foot Ulcers in Type 2 Diabetes
Chronic Foot Ulcers
Primary: Full Epithelialization of the Wound — 16; 8 participants — p=<0.05
Phase 3 N=196 Intravenous Iloprost in Subjects With Symptomatic Raynaud's Phenomenon Secondary to Systemic Sclerosis (Phase 3)
Raynaud's Phenomenon Secondary to Systemic Sclerosis
Primary: Change in Frequency of Symptomatic RP Attacks — -11.47; -12.73 Number of RP attacks per week — p=0.4210
N/A N=238 Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease
Peripheral Artery Disease · Amputation · Smoking
Primary: Positive Predictive Value of Digital ABI in Diagnosing PAD — 8; 2 Participants
N/A N=45 Scleroderma ARFI Imaging of the Skin
Scleroderma
Primary: Mean Skin Stiffness — 2.68; 2.07; 2.23; 2.27 meters per second — p=0.005
Phase 4 N=840 Alprostadil in Peripheral Arterial Occlusive Disease (PAOD) Stage IV
Peripheral Arterial Occlusive Disease
Primary: Complete Healing of Ischemic Necroses and Ulcerations at 12 Weeks After the End of Study Drug Treatment — 49; 43; 27; 30 participants — p=0.2587
Phase 3 N=130 Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers
Diabetic Foot Ulcers
Primary: Number of 100% Wound Closure — 55.74; 50.82 percentage of patients
N/A N=91 Intensive Insulin Treatment and Ischemic Foot Ulcer
Ischemic Foot Ulcer
Primary: Ischemic Foot Ulcer — 3; 10 participants
Phase 2 N=16 Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
Diabetic Foot Ulcer · Offloading
Primary: Lower Extremity Perfusion Change From Baseline to 4 Weeks — 167; 75 percentage of baseline perfusion
N/A N=23 Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers
Foot Ulcer, Diabetic
Primary: Tissue Oxygenation as Measured by Hyperspectral Imaging — 63.58; 61.91; 76.33; 77.55 percent concentration of oxyhemoglobin
N/A N=34 Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD
PVD · Arterial Ulcers
Primary: Mean Percent Reduction in Wound Surface Area — 72; 58 Percent reduction in wound surface area — p=0.086
Phase 2 N=6 Topical Sodium Thiosulfate and Fractional Carbon Dioxide Laser in Treating Dermatomyositis Associated Calcinosis
Calcinosis
Primary: Change in Dermatomyositis-associated Calcinosis of a Single Lesion by Assessing Its Severity as Measured by a Difference in Physician Calcinosis Visual Analog Scales…
N/A N=36 Perclose Multi-Access Duplex Ultrasound (DUS) Study
Arrhythmia
Primary: Number of Subjects With Major Vascular Complications by DUS Detection at Discharge — 0; 0; 0; 0 Participants
N/A N=144 Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)
Pressure Ulcers · Spinal Cord Injuries
Primary: Percent of Possible Self-Reported Skin Care Behaviors — 73.8; 74.1; 83.5; 79.5 % of Possible Self-Reported Behaviors
Phase 3 N=48 Beta Adrenergic Antagonist for the Healing of Chronic DFU
Chronic Diabetic Foot Ulcers · Diabetic Neuropathic Ulcers · Non Healing Wound
Primary: Percentage of Complete Wound Closure, as Assessed Over a 12 Week Period — 8; 7 Participants
N/A N=10 Tadalafil for the Treatment of Raynaud's
Raynaud
Primary: Number of Raynaud's Phenomenon Attacks Per Day — 2.4; 1.1; 2.0; 2.3 Raynaud's attacks per day
N/A N=15 Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis
Systemic Sclerosis · Scleroderma
Primary: The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the…
Phase 3 N=276 Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients
Diabetic Foot Ulcer
Primary: Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing — 68; 31; 23; 14 participants