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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | Experimental | Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 Laser | Device | Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension | Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer). | 5 months from time point zero / baseline |
| Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline | Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound. | 3 months after final laser session (5 months after time zero / baseline) |
| Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy | Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness. | baseline and 3 months after final laser session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Micheletti, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Who Show Improvement in Range of Motion, Flexion, and Extension | Range of motion (flexion, extension, supination, pronation) of the target joint (measured in degrees, using a goniometer). | Posted | Count of Participants | Participants | 5 months from time point zero / baseline |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | rAblative Fractional Laser for Sclerotic GVHD-Associated Joint | Range of motion limitations and joint contractures due to sclerotic GVHD across a specific joint / limb" CO2 Laser: Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints. Ultrasound: Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. Skin Biopsy: standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. Photography: Photography of the affected area / intended treatment area. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Left Brachial artery clot | Cardiac disorders | Non-systematic Assessment | Pt complained of L arm cramping beginning 1/21 was diagnosed with brachial artery clot on 1/26. Went to OR for thrombectomy. Now doing fine, anticoagulated. Please note laser treatment #1 for this study took place on 1/22 on contralateral wrist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at Treatment site (right foot) | Nervous system disorders | Non-systematic Assessment | Pt ( has existing lower extremity neuropathy) developed pain at laser treatment site within ~1 hour of treatment. Pain was moderate to severe but transient resolved with conservative measures Treatment discontinuation for this patient due to pain. |
Small number of study subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | Hospital of the University of Pennsylvania | 215-662-6722 | leahyd@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D054020 | Lasers, Gas |
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Ultrasound | Radiation | Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound. |
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| Skin Biopsy | Diagnostic Test | standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis. |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Number of Subjects With Evidence of Collagen Remodeling (Increased Dermal Echogenicity) Compared to Baseline | Measurement of skin echogencity (brightness) in comparison with pre-therapy images of the same areas using high-resolution ultrasound. | Posted | Count of Participants | Participants | 3 months after final laser session (5 months after time zero / baseline) |
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| Primary | Number of Subjects Who Show Decrease in Skin Thickness and Sclerosis With Collagen Remodeling as Measured by Before and After Skin Biopsies Biopsy | Trichcrome stain, collagen fiber number and thickness, Herovici stain, elastic fiber length, and dermal thickness. | Posted | Count of Participants | Participants | baseline and 3 months after final laser session |
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| 0 |
| 8 |
| 1 |
| 8 |
| 1 |
| 8 |
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| Biopsy site infection | Infections and infestations | Non-systematic Assessment | Pt experienced pain at the right forearm skin biopsy site the same day of the biopsy. Later developed scant fibrinous exudate vs minimal purulent drainage, possibly representing superficial skin infection. |
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| D000069453 |
| Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |