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.
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.
- 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:
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.
The subject will receive either:
- Cardinal Pro +Simultaneous Irrigation (NPWTi) - Negative Pressure Wound Therapy with
- Cardinal Pro (NPWT) Therapy (without Prontosan®) (See pictures on Page 15.)
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.
Diagnosis of diabetes mellitus Men/women ≥21 years old Foot or ankle wounds sized 5 cm2
-100 cm2 ABI≥0.5 or toe pressures >30 mmHg
Active Charcot arthropathy Unable to use NPWT at home Untreated bone or soft tissue
infection Unable to keep research appointments Active alcohol or substance abuse