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Still seeking patients for NYC Clinical Trial on ESWT

Posted by Dr.Man on 12/09/02 at 12:20 (102352)

We are three months into our FDA approved clinical study on the use of the Orbasone Pain Management System for proximal plantar fasciitis (Heel Pain Syndrome).This is the newest version of Extracorporeal Shock Wave Therapy devices.Since this is a clinical study certain criteria must be met along with 'Inclusion and Exclusion Criteria'.Briefly, the patient must have failed at least six months of conservative care for proximal plantar fasciitis.Must have received at least four types of modalities such as cortisone injections, oral madications, orthotics, stretching, physical therapy ect..Exclusion criteria would be if both heels hurt, if it is a diagnosis other than proximal plantar fasciitis, previous heel surgery or if the patient has a diagnosis of diabetes or other systemic disorder.This is a 'Double-Blinded Plecebo Study'. This means the patient may or may not receive the actual treatment.The end-point of the study is twelve weeks.There will be no cost to patients accepted into the study, however the facility will accept whatever fees are reimbursed by insurance. Dr.Mancuso, 133 E 54 St, NYC. (212)759-9090, E-Mail: (email removed)

Re: Still seeking patients for NYC Clinical Trial on ESWT

dave r on 12/09/02 at 12:24 (102354)

This is interesting. I thought this machine was pulled from use for people with plantar fasciitis?

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr.Man on 12/09/02 at 12:33 (102357)

The Orbasone System was in clinical use for a few years under a different approval. It was being use for heel pain with a published study documenting a 82% success rate. Orthometrix, the manufacturers of the device, have made a few modifications and now need to seek FDA approval for the treatment of Proximal Plantar Fasciitis.

Re: Still seeking patients for NYC Clinical Trial on ESWT

dave r on 12/09/02 at 12:44 (102360)

Ok thanks for explaining:)

Re: Still seeking patients for NYC Clinical Trial on ESWT

Ed Davis, DPM on 12/09/02 at 18:28 (102428)

Dave:

The machine itself had no problems and may have even been very successful--check with Dr. Z. The issue that did arise had to do with FDA approval having been extended under what the FDA interpreted as incomplete information provided to them by the manufacturer.
Ed

Re: Still seeking patients for NYC Clinical Trial on ESWT

Pauline on 12/10/02 at 11:36 (102560)

Wow,
This is a real first for ESWT. With all the posters seeking ESWT treatment you'd think they would be jumping at your offer. Do you plan to offer those patients that participate and get the sham treatment a real one for free at the end of the tests? Maybe if they know this is a possibility you may get the people you need.

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Zuckerman on 12/10/02 at 12:33 (102566)

The orbasone is alive and doing well. It has been given a second life

Re: Still seeking patients for NYC Clinical Trial on ESWT

dave r on 12/10/02 at 12:38 (102568)

Are you using it again in your office Dr. Z?

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Z on 12/10/02 at 16:37 (102597)

We use the dornier Epos.

Re: Still seeking patients for NYC Clinical Trial on ESWT

DrMan on 12/10/02 at 21:20 (102641)

We will be offering the actual ESWT procedure to those patients in the study who received the placebo. We would have to petition the FDA to be allowed to use the device on them after the study is completed yet before final FDA approval. The inside word is that this should be possible. There will, however, be a minimal cost to the patient in the event insurance doesn't approve payment.

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Z on 12/10/02 at 21:27 (102642)

I would think that the FDA should allow a cross over from placebo to treatment . In the past they have with both the Epos and the Ossatron.
I hope that all is well. Say hello to Dr. Swallyee. He is a great friend of Dr. Z's. He taught he everything you need to know about the big O

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Z on 12/10/02 at 21:29 (102643)

E-mail Dr. Z at (email removed). I may been able to help you

Re: Still seeking patients for NYC Clinical Trial on ESWT

dave r on 12/09/02 at 12:24 (102354)

This is interesting. I thought this machine was pulled from use for people with plantar fasciitis?

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr.Man on 12/09/02 at 12:33 (102357)

The Orbasone System was in clinical use for a few years under a different approval. It was being use for heel pain with a published study documenting a 82% success rate. Orthometrix, the manufacturers of the device, have made a few modifications and now need to seek FDA approval for the treatment of Proximal Plantar Fasciitis.

Re: Still seeking patients for NYC Clinical Trial on ESWT

dave r on 12/09/02 at 12:44 (102360)

Ok thanks for explaining:)

Re: Still seeking patients for NYC Clinical Trial on ESWT

Ed Davis, DPM on 12/09/02 at 18:28 (102428)

Dave:

The machine itself had no problems and may have even been very successful--check with Dr. Z. The issue that did arise had to do with FDA approval having been extended under what the FDA interpreted as incomplete information provided to them by the manufacturer.
Ed

Re: Still seeking patients for NYC Clinical Trial on ESWT

Pauline on 12/10/02 at 11:36 (102560)

Wow,
This is a real first for ESWT. With all the posters seeking ESWT treatment you'd think they would be jumping at your offer. Do you plan to offer those patients that participate and get the sham treatment a real one for free at the end of the tests? Maybe if they know this is a possibility you may get the people you need.

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Zuckerman on 12/10/02 at 12:33 (102566)

The orbasone is alive and doing well. It has been given a second life

Re: Still seeking patients for NYC Clinical Trial on ESWT

dave r on 12/10/02 at 12:38 (102568)

Are you using it again in your office Dr. Z?

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Z on 12/10/02 at 16:37 (102597)

We use the dornier Epos.

Re: Still seeking patients for NYC Clinical Trial on ESWT

DrMan on 12/10/02 at 21:20 (102641)

We will be offering the actual ESWT procedure to those patients in the study who received the placebo. We would have to petition the FDA to be allowed to use the device on them after the study is completed yet before final FDA approval. The inside word is that this should be possible. There will, however, be a minimal cost to the patient in the event insurance doesn't approve payment.

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Z on 12/10/02 at 21:27 (102642)

I would think that the FDA should allow a cross over from placebo to treatment . In the past they have with both the Epos and the Ossatron.
I hope that all is well. Say hello to Dr. Swallyee. He is a great friend of Dr. Z's. He taught he everything you need to know about the big O

Re: Still seeking patients for NYC Clinical Trial on ESWT

Dr. Z on 12/10/02 at 21:29 (102643)

E-mail Dr. Z at (email removed). I may been able to help you