Ablative Fractional Laser for Sclerotic GVHD-Associated Joint Contractures



Status:Active, not recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:9/30/2018
Start Date:February 2014

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Ablative Fractional Laser Resurfacing for the Treatment of Scars and Contractures Caused by Sclerotic Skin Changes Chronic Graft Versus Host Disease

Graft versus host disease (GVHD) is a common complication of allogeneic stem cell
transplant.Chronic GVHD is characterized by skin thickening and tightening. Advanced
sclerosis can lead to reduced range of motion and incapacitating joint contractures. Once
present, there are few therapeutic options. We will treat sclerosis and limb contractures
with an ablative fractional laser, a device FDA-approved for scar treatment. This approach
has successfully treated contracturesdue to burn scars.


Inclusion Criteria:

- Subjects must be able to give informed consent

- All adult patients (18 years of age or older) Severe sclerotic skin changes of chronic
graft versus host disease meeting a score of 3 on the NIH consensus criteria for organ
scoring of chronic GVHD,

- a score defined by deep sclerotic features with hidebound skin which cannot be pinched
together, resulting in impaired motion.

- According to the NIH criteria, the patient need not have widespread cutaneous GVHD;
hidebound skin OR impaired mobility receive a score of 3 (highest score).

- Demonstrable range of motion limitations and joint contractures due to sclerotic GVHD
across a specific joint / limb amenable to laser therapy must be present. - - Patients
must note an inability to bend the joint (e.g. foot, wrist, elbow) freely which
compromises the ability to perform specific tasks (e.g. walking up or down stairs,
grabbing / making a fist, lifting or raising thearms over the head). As these
functional limitations are by their nature subjective (and NIH scoring criteria are
themselves subjective) determination of eligibility will be made by the investigator.

- ECOG Performance Status shall be 0-3

Exclusion Criteria:

- Persons unable to provide informed consent Pregnant or nursing women, or children
under age 18

- Active infections such as herpes simplex virus (HSV) Acute, untreated medical problems
such as poorly-controlled diabetes, decompensated heart failure, etc.

- There are no specific contraindications to use of the laser based on skin
pigmentation, sun sensitivity, history of keloids, use of specific medications, etc.

- Appropriateness for trial entry will be determined on an individual basis by the study
investigators.

- Patients with ECOG Performance Status 3 will be excluded.

- Patients with ANC 1500,PLT 50, or Hgb 8.0 will be excluded.
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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from
Philadelphia, PA
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