Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02463487 |
| Other study ID # |
STU 092014-016 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2, 2015 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
July 2023 |
| Source |
University of Texas Southwestern Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators plan a randomized clinical trial of 150 patients with infected
diabetes-related lower extremity wounds to compare the clinical and economic effectiveness of
negative pressure wound therapy with continuous irrigation and negative pressure wound
therapy without irrigation.
Description:
The investigators will enroll 150 patients from two centers: The University of Texas
Southwestern University Hospital and Parkland Hospital. The investigators will screen and
enroll patients with wounds in the inpatient setting. Patients will be randomized to receive
traditional NPWT or NPWT with continuous irrigation while they are hospitalized. The average
hospitalization for patients that receive NPWT is 13.3 days. Patients that do not have their
wound surgically closed during hospitalization will be discharged with negative pressure
wound therapy for up to a total of four weeks of therapy. After discharge from the hospital,
subjects will be seen twice weekly by home health, and will be evaluated in clinic every 7
days (±7 days) up to a total of 16-week period or until 30 days after the wound heals.
Study Procedures:
Screening Procedures
- Review and sign the Informed Consent and HIPAA Authorization
- The study doctor will review the inclusion and exclusion criteria
- Demographics (such as age, gender, race or ethnicity)
- Physical exam
- Sitting blood pressure and pulse
- Height and weight
- Collection of the medical and surgical history
- Collection of the history of the wound
- Wound assessment(s)/Debridement - various tests and measurements to assess the sensation
(feeling) and circulation (blood flow) in the subject's feet and lower legs. None of
these tests are invasive (using needles), uncomfortable or have risks greater than
standard care.
- Wound imaging - photographs and images of the subject's wound using acetate tracings, a
digital camera and an ARANZ camera (a special type of camera that uses computer software
to calculate the volume of the wound)
- Hyperspectral imaging
- Vascular/Neurological evaluation
- Results of standard-of-care laboratory tests including a white blood cell count, blood
chemistry (tests to see how well organs, such as the liver and kidneys are working), and
blood glucose. Results of a serum pregnancy test (standard care for women of
child-bearing potential as part of pre-op labs) will also be collected. About 2
tablespoons of blood will be drawn for these tests.
- Collection of a list of the subject's current medications, including prescriptions,
over-the-counter medications, supplements and herbals.
This visit will last about 2 hours.
If the subject qualifies for the study, they will participate in the following procedures:
Group Assignment
If the researchers believe the subject can take part in this study, s/he will be assigned
randomly (like a flip of a coin) to receive one of the following therapies:
- Negative Pressure Wound Therapy with Irrigation
- Negative Pressure Wound Therapy without Irrigation
The group is assigned randomly (like flipping a coin). The sponsor or researchers do not know
in advance what group assignment each subject will receive. Neither the subject nor the
researchers will be allowed to choose which group s/he is assigned to.
Study Intervention
The subject will receive either:
- Cardinal Pro +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with
Prontosan®, or
- Cardinal Pro (NPWT) Therapy (without Prontosan®)
Assigned therapy will continue in the hospital until the physician determines that the wound
is ready for closure. If the subject's wound is healing, study therapy will be discontinued
and standard dressings will be applied. If surgical closure is needed, the subject will
return to the Operating Room for a procedure to close the wound.
If the wound is not ready for closure during the hospital stay, subjects will continue NPWT
at home for the remainder of the 4 weeks of treatment. NPWT at home will be without
irrigation (KCI VAC Via®).
Procedures and Evaluations during the Research The study therapy will only be given while the
subject is in the hospital. S/he will continue the therapy for up to 4 weeks or until the
wound is closed. Once the therapy is stopped s/he will continue to be followed by the study
doctor. After the subject is released from the hospital s/he will need to see the study
doctor Every 7 days (±7 days). If the subject's wound does not heal before 56 days after
his/her first surgery then s/he will no longer be taking part in the study. The study doctor
will continue to check the wound. If the wound closes, s/he will see the study doctor 30 days
later to have the closed wound checked.
12 Month Extension:
After the end of the defined study period, the patients will be followed observationally by
their electronic medical records for 12 months as it would not be feasible to ask them to
return for an in-person evaluation as: patients have moved, no longer have correct contact
information, as well as it would create a financial hardship on the patients to return for
further visits. In order to more appropriately determine long term results from
participation, a longer period of time of follow up is necessary. Related outcomes that we
would like to follow over a 12-month duration are incidence of new foot ulcerations,
re-ulceration of a previously healed foot wound, healing and time to healing of patients who
took longer than the current study allows, duration of antibiotics received for foot
infections, re-admissions to the hospital, need for subsequent surgery, amputation, loss of
limb, and death. This expanded follow up period would provide valuable information to the
long-term outcomes and complications of this high risk population and will help direct how
future efforts may be better focused to reduce complications and improve outcomes.
