Patients with dermatomyositis and refractory skin disease on steroids and one steroid-sparing agent.

Dermatomyositis, Adult Type

Patients with refractory cutaneous dermatomyositis will be started on apremilast 30 mg twice a day in addition to a stable dose of their treatment regimen (including steroids and steroid sparing agents).

Apremilast 30mg

Tulane University

Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis

A Phase 2, Open Label Single Arm Study for Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis

Cutaneous dermatomyositis disease area and severity index (CDASI) activity score is a validated tool to measure skin disease activity in dermatomyositis. The overall response rate (ORR) includes partial and complete responses. Complete response is defined by a CDASI activity score of zero. Partial response is defined by a decrease of CDASI activity score of at least 4 points. Calculation is performed as the CDASI activity score at 3 month(s) minus the score at baseline. Missing data will be handled using the last observation carried forward approach (LOCF).
CDASI activity score: Units on a scale from 0-100. Higher scores represent worse outcome.

The proportion of participants experiencing adverse events and serious adverse events will be measured over 7 months period (6 months during the study and 1 month follow up).

The durability of response will be measured using the CDASI activity score at 6 months minus CDASI activity score at 3 months. Complete response durability is defined as zero or minus difference between CDASI activity score at 6 months and CDASI activity score at 3 months. Partial response durability is defined as >4 points difference between CDASI activity score at 6 months and CDASI activity score at 3 months. Missing data will be handled using the last observation carried forward approach (LOCF).
CDASI activity score: Units on a scale from 0-100. Higher scores represent worse outcome.

Complete delayed response is defined by a CDASI activity score of zero at 6 months. Partial delayed response is defined by a decrease of CDASI activity score of at least 4 points at 6 months compared to baseline. Calculation is performed as the CDASI activity score at 6 months minus the score at baseline. Missing data will be handled using the last observation carried forward approach (LOCF).
CDASI activity score: Units on a scale from 0-100. Higher scores represent worse outcome.

Dermatology Life Quality Index (DLQI) is a validated tool to measure quality of life in patients with skin disease. Complete response is defined by a DLQI of zero at 3, and 6 months. Partial response is defined by a decrease of DLQI of at least 5 points at 3, and 6 months compared to baseline. Calculation is performed as the DLQI at 3, and 6 months minus the score at baseline. Missing data will be handled using the last observation carried forward approach (LOCF).
Units : Units on a scale from 0-30, higher scores represent worse outcome.

Calculate the mean change in muscle enzymes value creatine kinase and aldolase at 3 and 6 month(s) compared to baseline in patients with muscle disease.
Units: U/L, higher numbers represent worse outcomes

MMT-8 (Manual Muscle Testing-8) score is a validated tool to assess muscle strength. Calculate the mean change in MMT-8 score at 3 and 6 month(s) compared to baseline in patients with muscle disease.
Units: Units on a scale. Scale goes from 0-150. 150 is perfect strength.

Skin biopsies from lesional skin will be performed before treatment with apremilast and after 3 months of treatment to assess changes in gene expression profiling and immunohistochemistry stain. Gene expression profiling will be analyzed using inferential statistics with a False Discovery Rate (FDR) of < 0.05.

Data and research resources generated by this study will be made available to the research community and to the public at large. This strategy includes, but not limited to, presentations (poster or oral) at local, national, and international meetings; published abstracts, and journal articles (peer reviewed). Contact information will be provided in publications for direct inquiries of researchers. Data generated from sequencing and gene expression profiling will be deposited into the Gene Expression Omnibus (GEO), NCBI, to be accessible by general public. The study protocol will be shared with other researchers on the clinical trial.gov website. No identified personal patient informations will be shared.

This group will be getting all the routine work up including Duplex scan . we will add request for inflammatory and coagulation markers in their blood samples before and after intervention . The pre-op blood sample will be collected within the 24 hours before intervention and the post intervention in the 24 hrs after (second RIPC window). The repeated duplex scan will be schedule after 6 months.

Remote Ischemic Preconditioning Group (RIPC):This group will have all the tests as for the control group with the additional component will be preconditioning. One hour prior to procedure candidates in this group will have structured intermittent periods of induced remote ischaemic preconditioning using standard blood pressure cuffs. The cuff will be inflated to 200 mmHg applied for 5 minutes alternating with 5 minutes rest to the total of 4 cycles, which needs 40 minutes.

Peripheral Vascular Diseases

standard blood pressure cuffs applied to upper limb . The cuff will be inflated to 200 mmHg applied for 5 minutes alternating with 5 minutes rest to the total of 4 cycles

Remote Ischemic Preconditioning

University Collage Hospital Galway

Limerick University Hospital

Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty

Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty: A Pilot Randomized Control Trial

using Duplex scan 30% stenosis increase in time of flow up. Increase of less than or 50 % stenosis to 70% or more. Loss of 50% of gain in luminal diameter.

calculate the change in ABI pre and post intervention

Documents changes pre and post intervention

Demographic data Smoking DM Lesion type/site Ischemic heart disease Anti- coagulation and Antibiotic usage

bola/anti-inflamator

Evaluating Safety & Efficacy of Apremilast in the Treatment of Cutaneous Disease in Patients With Recalcitrant Dermatomyositis

Effects of Remote Ischemic Preconditioning on Restenosis Post Lower Limb Revascularization Angioplasty

Baza e të dhënave më e plotë e bimëve medicinale e mbështetur nga shkenca