A Multi-center, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
A Multi-center, Randomized Controlled Clinical Investigation Evaluating a Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
The purpose of this clinical investigation is to assess performance of the Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
The economic burden of DFUs costs the United States over $50 billion each year. The cost to treat one subject with DFUs ranges from $11,700 to $16,883. Although approximately 70% of DFUs are shown to heal with good SOC, at least 30% become chronic wounds. These non-healing wounds are at greater risk for infection and lower extremity amputation. Consequently, good standard of care therapy is important for subjects with chronic DFUs to improve subject outcomes, lower treatment costs and reduce the risk of complications.
The removal of necrotic tissue such as slough, eschar, and underlying biofilm constitutes one of the most important parts of standard of care (SOC). Currently, a variety of techniques are used to debride chronic wounds, such as larval therapy, autolytic and enzymatic methods, monofilament polyester fiber pads or brushes, and mechanical debridement with curettes and scalpels. It has also been demonstrated that more frequent debridement, on average, results in faster wound healing. While regarded as the "gold standard," sharp debridement requires considerable experience of clinicians to ensure that contaminated and devitalized tissue is entirely removed without extensively damaging surrounding healthy tissue. Moreover, a recent research has demonstrated that even when surgical debridement is well-conducted so that it removes the majority of biofilm, within 72 hours, biofilm often re-establishes itself. Given that perhaps 60% of chronic wounds have been found to harbor biofilm, it is challenging to keep such wounds free of biofilm so that the wound-healing process can be sustained. Consequently, any method that could potentially remove more biofilm and/or prevent its recurrence could improve the wound healing trajectory.
Medaxis Debritom+™ cleans and stimulates acute and chronic wounds precisely in a tissue-preserving manner. Its high-pressure micro fluid jet removes slough such as fibrin, necrosis or biofilm, as well as foreign bodies, in effect providing an efficient irrigation and debridement of contaminated wounds. The purpose of this clinical investigation is to assess performance of Medaxis Debritom+™ and to collect subject outcome data in the treatment of diabetic foot ulcers (DFU) vs Standard sharp debridement.
There are two arms in the study:
Arm 1: The Experimental Arm , that will include SOC Therapy. SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), use of the Medaxis Debritom+™ micro jet to clean the wound followed by a wound care covering ( Fibracol dressing or equivalent) along with a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).
Arm 2: The Standard of Care Arm. The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, followed by a wound care covering (Fibracol dressing or equivalent) along with a moisture retention dressing and a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compression wrap (DynaflexTM or equivalent).
Inclusion Criteria:
Exclusion Criteria: