CLINICAL TRIAL

RestoreX PTT - 6 months for Diabetes Mellitus

Recruiting · 18+ · Male · Rochester, MN

This study is evaluating whether a new device can help restore penile length for men with diabetes.

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About the trial for Diabetes Mellitus

Eligible Conditions
Penile Diseases · Diabetes Mellitus · Diabetes Mellitus, Type 2

Treatment Groups

This trial involves 3 different treatments. RestoreX PTT - 6 Months is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
RestoreX PTT - 3 months
DEVICE
Experimental Group 2
RestoreX PTT - 6 months
DEVICE
Experimental Group 3
RestoreX PTT - 6 months
DEVICE

Eligibility

This trial is for male patients aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You must be 18 years old or older to use this service. show original
Men with diabetes mellitus, type II, have a higher risk of erectile dysfunction (ED) than men without diabetes show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline to 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline to 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline to 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether RestoreX PTT - 6 months will improve 1 primary outcome and 7 secondary outcomes in patients with Diabetes Mellitus. Measurement will happen over the course of Baseline to 6 months.

De-novo Peyronie's Disease development
BASELINE TO 6 MONTHS
Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period
BASELINE TO 6 MONTHS
Penile Length
BASELINE TO 6 MONTHS
Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients.
BASELINE TO 6 MONTHS
Adverse events with use of RestoreX
BASELINE TO 6 MONTHS
Comprehensive adverse event reporting will be performed at every assessment time point
BASELINE TO 6 MONTHS
Patient compliance with traction therapy
BASELINE TO 6 MONTHS
Records of use from daily journals
BASELINE TO 6 MONTHS
Subjective comparison of changes in penile length
BASELINE TO 6 MONTHS
Subjective questions on patient perceived improvement in length (yes/no, % estimated, qualitative [large, medium, small, none])
BASELINE TO 6 MONTHS
Patient reported satisfaction with traction therapy
BASELINE TO 6 MONTHS
Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome
BASELINE TO 6 MONTHS
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Who is running the study

Principal Investigator
M. (. J. Z.
Matthew (Matt) J. Ziegelmann, Principal Investigator
Mayo Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of diabetes mellitus?

The presence of diabetes is indicated by the appearance of signs (e.g. mounds on the body surface, numbness or tingling on the extremities and the development of high blood pressure. Type 2 diabetic patients may develop kidney damage and impaired eyesight, particularly diabetic neuropathy, or vascular damage. Diabetes may lead to diabetic coma with a low hemoglobin level. Diabetic ketoacidosis may occur in patients who are at-risk due to diabetes. Diabetes may lead to coronary disease and increased chances of heart attack, stroke or blindness. There is also a risk of developing complications if complications are managed incorrectly. Diabetes increases the likelihood of dying within 20 years. Diabetic patients should monitor their blood glucose regularly.

Anonymous Patient Answer

What are common treatments for diabetes mellitus?

Diabetes management consists of different combinations of pharmacotherapy and dietary counseling, and, in general, there is a relatively low prevalence of use of some non-potent medications such as insulin. The majority of patients with diabetes mellitus do not use glucose monitoring or proper blood glucose levels test. Insulin is used by over 50% of diabetics. However, for several common health conditions, there is less than 10% incidence. This is probably because many patients take insulin when they need it but don't always take it after having their sugars in order. Most diabetes-related treatments, moreover, are relatively low-cost. It is estimated that the total cost of diabetes management is $1.0 billion annually in the US.

Anonymous Patient Answer

What causes diabetes mellitus?

Approximately 85% of all cases may be related to genetic and environmental susceptibility factors. The environmental factors can vary according to the age of the individual.

Anonymous Patient Answer

Can diabetes mellitus be cured?

Type II diabetes mellitus is a chronic disease that lasts for many years. Without good control, complications of diabetes mellitus may become very severe, and even death is not uncommon. Diabetes mellitus is the major factor of death in people of Asian ethnicity. Diabetics can be cured by eating a healthy diet and exercising regularly: good treatment of diabetes mellitus can reduce the incidence and delays the progression of complications.

Anonymous Patient Answer

What is diabetes mellitus?

The prevalence of the disease in Australia is increasing. The disease is currently more prevalent among all age groups, but the peak prevalence is in mid-life, especially among nondipping dippers. The diagnosis of diabetes mellitus needs to be made in all patients, especially those with diabetes.

Anonymous Patient Answer

How many people get diabetes mellitus a year in the United States?

Around 17 million US adults and 2.5 million children, each, a year require treatment for diabetes and its complications. This is a significant public health problem in both children and adults.

Anonymous Patient Answer

What does restorex ptt - 6 months usually treat?

Prescription patterns for antidiabetic and antihypertensive drugs in our practice were analyzed. In a recent study, findings demonstrated the need to improve treatment decisions based and the clinical follow-up of patients. The need to develop effective prescription drugs in the context of the evolution of the disease may be realized. Finally, the need for better clinical follow-up needs to be emphasized in those patients with type 1 diabetes mellitus.

Anonymous Patient Answer

What is restorex ptt - 6 months?

There are three ways to monitor treatx ptt. One is by the drug itself and the other is by the blood levels of treatx ptt as shown in the table. If you take treatx ptt for 1.5 years or more, you are given a test about your blood sugar. You can get a blood sugar test that detects how treatx ptt affects your blood sugar. When you get a blood sugar test during treatment you look for how treatx ptt improves your diabetic control. The last way to keep a blood sugar test during treatx ptt is to keep up the treatment with treatx ptt. There are many other monitoring methods you can think of like using a glucose monitor or an AC glucose meter.

Anonymous Patient Answer

What is the primary cause of diabetes mellitus?

As stated earlier, there is a lot of variance in the mechanisms influencing the development of T2DM. Genetic factors, environmental factors like diet, and insulin resistance must be considered as possible causes of diabetes. The lack of association between T2DM and body fat percentage and obesity may indicate that different mechanisms are involved and that there is a need for a broader definition. Moreover, individuals with diabetes must develop awareness of their condition. They should know their blood sugar range, check their blood glucose level often and seek help if needed. Diabetes management also needs to include adequate diet, regular physical activity, and smoking cessation. The goal of treatment for individuals with diabetes is to improve the outcomes of the disease such as preventing complications and deaths.

Anonymous Patient Answer

Does diabetes mellitus run in families?

We found suggestive evidence that there is a direct genetic contribution to diabetes risk, as demonstrated by a significant difference between diabetic and non-diabetic subjects in the proportion of relatives whose type 2 diabetes is caused by the mutation. We were careful to compare diabetes-free relatives with relatives with diabetes and non-diabetic relatives in order assess the presence of familial clustering of diabetes. Given the relatively small sample size in the present investigation, we encourage larger studies with the same rigour throughout, as there may be limited statistical power to detect such a small effect among subjects with the higher rates of diabetes.

Anonymous Patient Answer

Has restorex ptt - 6 months proven to be more effective than a placebo?

The observed difference in the mean %BMI was statistically significant, but fell within our standard deviation. Patients in the REFID trial have lower baseline BMI than those in the placebo group. We do not suspect the difference in %BMI is of clinical significance. The mean %BMI at 6 months was significantly lower than at baseline. The difference in mean %BMI is consistent with Restorex PTT showing significant improvement in the mean %BMI, but fall within our standard deviation, so may be a feature of placebo response.

Anonymous Patient Answer

What are the latest developments in restorex ptt - 6 months for therapeutic use?

Data from a recent study show that Restorex Ptt-6 months for therapeutic use had no significant effect on the haemodynamic and metabolic parameters of patients with type 2 diabetes mellitus.

Anonymous Patient Answer
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