Oxandrolone to Heal Pressure Ulcers

NCT00101361 | Terminated Phase 3 Results DMC

• 1 other identifier: 535
• Study Type: interventional
• Target: 212
• Locations: 2 countries
• Sites: 16

Brief Summary

This study is designed to determine whether the use of oxandrolone, an anabolic steroid, can heal pressure ulcers in persons with spinal cord injury (SCI). In a Feasibility Study, three VA SCI Units will screen and randomize patients into treatment with oxandrolone or with placebo. Eleven other sites will screen patients to determine eligibility but will not treat patients with the agent. Following the Feasibility Study, all sites will participate in a blinded, randomized treatment study. A total of 400 patients will be enrolled over a four-year period. Any patient in a participating unit who has chronic SCI and a difficult-to-heal pelvic ulcer will be eligible for the study if other entry criteria are met. All enrolled patients will be followed for a period of 24 weeks to determine whether their target pressure ulcers heal. Those who are healed will be followed for an additional four weeks to determine whether the ulcer remains healed.

Conditions

Pressure Ulcer

Keywords

dermatologic; skin; clinical trial; androgen/anabolic

Outcome Measures

Primary Outcomes (1)

• A Healed Pressure Ulcer

  Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.

  healing was measured from randomization to full healing or 24 weeks, whichever occured first.

Study Arms (2)

1

ACTIVE COMPARATOR

oxandrolone

Drug: Oxandrolone

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Oxandrolone DRUG

Patients will receive oxandrolone (10mg BID) until full healing occurs or for 24 weeks, which ever comes first.

1

Placebo DRUG

Patients will receive an identically appearing placebo capsule until full healing occurs or for 24 weeks, which ever comes first.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCREENING PHASE:
• Male or female inpatient with SCI or equivalent spinal cord damage.
• At least one Stage III or IV (including a severe wound, \<260cm2) pressure ulcer of the pelvic region.
• TREATMENT PHASE:
• \. documentation (through screening phase) of difficult to heal (defined as \<30% area reduction) or worsening status of the pressure ulcer for at least 28 days as inpatient (screening phase)

You may not qualify if:

• SCREENING PHASE:
• Persons who are candidates for and elect to have reconstructive flap surgery of the TPU;
• Persons with known osteomyelitis who have not been, or refuse to be, adequately treated with appropriate antibiotic treatment for at least 6 weeks and/or appropriate surgical procedures, as determined by the patients' physician, as well as patients who have not had resolution of osteomyelitis after 3 months of antibiotic and/or surgical care.
• Psychopathology (documentation in the medical record or history of self-abusive behavior specific to pressure ulcer healing which may or may not include major or minor psychiatric illness) that may conflict with study objectives;
• Previously diagnosed active malignant disease;
• Suspicion of skin cancer at the pressure ulcer site (a biopsy-negative patient is not excluded, nor is a biopsy-positive patient excluded after a curative excision of the lesion);
• Radiation therapy in the pressure ulcer field at anytime during the patient's lifetime;
• Life expectancy less than 12 months;
• Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
• AIDS patients at immunological risk of infectious complications defined as any of the following: (1) CD4 count \<100 cells/ L or (2) CD4 count 100 to 200 cells/ L and WBC \< 4,000 cells/ L or (3) a confirmed viral load within the past 6 months;
• Administration of oxandrolone or another anabolic agent (not including testosterone replacement therapy) within the past 6 months;
• A known hypersensitivity to anabolic steroid medications (specifically oxandrolone);
• Coronary athersclerosis with unstable angina pectoris or a history within the past 3 months of an acute myocardial event or decompensated congestive heart failure.
• Inability or unwillingness of the subject or surrogate to provide informed consent.
• TREATMENT PHASE:

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (16)

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

VA Medical Center, Augusta

Augusta, Georgia, 30904, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, 02301, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Zablocki VA Medical Center, Milwaukee

Milwaukee, Wisconsin, 53295-1000, United States

Location

VA Medical Center, San Juan

San Juan, 00921, Puerto Rico

Location

Related Publications (1)

• Bauman WA, Spungen AM, Collins JF, Raisch DW, Ho C, Deitrick GA, Nemchausky BA, Goetz LL, Park JS, Schwartz M, Merritt JL, Jayawardena V, Sandford P, Sabharwal S, Holmes SA, Nasar F, Sasaki R, Punj V, Zachow KF, Chua WC, Thomas MD, Trincher RC. The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial. Ann Intern Med. 2013 May 21;158(10):718-26. doi: 10.7326/0003-4819-158-10-201305210-00006.

  PMID: 23689765 DERIVED

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Oxandrolone

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Selection of severe wounds may have reduced treatment response. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between groups.

Results Point of Contact

• Title: William A. Bauman, M.D.
• Organization: James J. Peters VA Medical Center

william.bauman@va.gov

718-584-9000

Study Officials

• William Bauman, MD

  VA Medical Center, Bronx

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: August 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 20, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-11

Locations

US (15); PR (1)