Clinical Trials

Inclusion Criteria:

• Adults greater than 18 years old.
• Males and females.
• Stage III pressure ulcers measuring 5 cc – 36 cc in volume (as measured by filling the wound with Normal Saline).
• Inpatient or outpatient treatment of pressure ulcers.
• Diabetic Foot Ulcer Stage 1 or 2 of any size.
• Co-morbidities may include:
  • Peripheral Vascular Disease (PVD);
  • Using Rutherford Scale: Stage 0-4 will be included;  
  • Stage 0 – Asymptomatic;
  • Stage 1 – Mild claudication;
  • Stage 2 – Moderate claudication; The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
  • Stage 3 – Severe claudication
  • Stage 4 – Rest pain
  • Stage 5 – Ischemic ulceration not exceeding ulcer of the digits of the foot;
  • Stage 6 – Severe ischemic ulcers or frank gangrene;
  • Coronary Artery Disease (CAD);
  • Chronic Renal Disease (CRD);
  • Can be stages 1-5 (and based on clinical judgment of the physician);
  • Chronic Liver Disease (CLD);
  • MELD* score  < 11;
  • Hypertension (HTN);
  • Normal, Prehypertensive, Hypertensive Stage 1 and 2 are included.  Hypertensive crisis (>180/ >110mmHg) is excluded from the study and subject may be re-eligible when adequate BP control is maintained.
  • Diabetes;
  • HbA1c < 9.
• The ability of subjects to give appropriate consent or have an appropriate representative available to do so.
• The ability of subjects to return for weekly wound assessments.

Exclusion Criteria:

• Patients with allergies to TISSEEL, Tegaderm, or silicon.
• Diabetics with poor glucose metabolic control exhibited by an HbA1c > 9.
• Target wounds that are in close proximity to potential cancerous lesions.
• Patients who require Negative Pressure Wound Therapy (NPWT), limb amputation, or surgical intervention at the target wound at the time of screening.
• Wounds located on the face.
• Patients with Stage 5 or 6 Peripheral Vascular disease (specifically, wounds that are caused by peripheral vascular disease such as leg ulcers).
• Osteomyelitis of the side (Ipsilateral limb) of the treated wound.
• Wound abscess.
• BMI of < 16.
• Clinical signs of critical colonization or local infection.
• Pregnancy.
• Prolonged (> 6 months) use of steroids.
• Patients on active regimen of chemotherapy.
• Patients receiving radiation in proximity of wound.
• Decompensated chronic liver disease; i.e., patients who have experienced hepatic encephalopathy, ascites,  bleeding due to portal hypertension and jaundice or in patients with chronic liver disease with a Model for End-stage Liver Disease (MELD) scores > 11 will not be included.
• End of life.

Eligibility last updated 12/7/21. Questions regarding updates should be directed to the study team contact.