Successful Treatment of Recalcitrant Foot Ulcer

Phoenix, AZ

54 y.o. male with type-2 diabetes, peripheral neuropathy, and peripheral artery disease with history of a persistent DFU that was seen as a 2nd opinion to toe amputation.  The DFU presented with necrotic tissue, debris, mild drainage and required off-loading shoes.  Several different modalities and therapeutic approaches were used over the past 2.5 years including skin substitutes and grafts.

Following sharp debridement and 1 application of Architect® Stabilized Collagen Matrix, the wound was completely closed within 8 weeks.

Pre-Application

Persistent Diabetic Leg Ulcer, not healed after 2.5 years of treatment, including several other skin substitutes and grafts.

4 Weeks Post-Op

Progress of wound closure was excellent by week 4. Outer dressings were removed and wound was cleaned with sterile saline and redressed with Architect®, Steri-Strips®, and moistened gauze.

8 Weeks Post-Op

Wound had completely closed and the remaining remnant of Architect® was removed.  The patient was seen two weeks later and the wound remained closed.


Successful Treatment of a 4-Year Recalcitrant Broken Glass Foot Wound

Phoenix, AZ

35 y.o. female patient lacerated the plantar surface of her right foot with glass.  During the course of four years, the wound has undergone multiple procedures including incisions and drainage, rotational skin grafts, and treatments of advanced wound-healing products.  The wound remained open with no progression toward healing.  Following a course of doxycycline, and application of Architect®, the wound was closed in 10 days.  

Pre-Application

4 Year old full-thickness plantar right food wound.  No neuropathy noted and pedal pulses intact.

Architect® was packed into the wound appendages for complete wound coverage and secured in place with Steri-Strips® and pressure dressings to prevent shifting of the graft.

The foot was off-loaded with a trauma shoe.  The patient was instructed on daily dressing changes and not to get the foot wet.

10 Days Post-Op

Patient returned 10 days later with complete closure of the recalcitrant wound. Steri-Strips® were still in place upon arrival to the office.

No additional debridement was necessary, though thick surrounding callus was debrided.

Patient returned 12 days later and wound remained closed.


Successful Treatment of a Chronic Diabetic Foot Ulcer

Progression of the Stabilized ECM during a 9 week period. The DFU was healed with just 1 application.

Pre-Application

Chronic DFU. Wound was debrided prior to application of the Stabilized ECM, sutured around the edges followed by moistened saline dressings and off-loading.

1 Week Post-Op

Stabilized ECM is dry along the edges and moist in the middle.
*Maintaining intimate contact with the wound bed is recommended.

3 Weeks Post-Op

Stabilized ECM is visibly smaller and dry along the edges.
*Hanging edges may be trimmed as wound closes.

4 Weeks Post-Op

Wound edges are visibly smaller.
*Maintaining appropriate moisture balance is recommended.

5 Weeks Post-Op

Stabilized ECM still smaller and sutures were removed by physician.
*Sutures may be removed upon clinical discretion as the wound edges recede.

7 Weeks Post-Op

Stabilized ECM was no longer attached, wound continued to be off-loaded with saline dressings.

9 Weeks Post-Op

Final follow-up, wound fully closed with 1 Application.


Successful Treatment of Recalcitrant Venous Leg Ulcer

Tempe, AZ

82 y.o. female with 2 year old Venous Leg Ulcer.  Previous treatment with human skin substitute failed.  The VLU was healed in 12 weeks with just 1 application of Architect®.

Pre-Application

Venus Leg Ulcer, not healed after 2 years of treatment, including human cellular products.

2 Weeks Post-Op

Architect® secured using Steri-Strips®.

12 Weeks Post-Op

Wound Healed with 1 Application of Architect®.


Diabetic Foot Ulcer with Exposed Bone

Lafayette, LA

68 y.o. male with plantar DFU.  DFU was healed in 9 weeks with just 1 application of Architect®.

Pre-Application

Diabetic Foot Ulcer with Exposed Bone.

9 Weeks Post-Op

Wound Healed with 1 Application of Architect®.


Stabilized ECM vs. Human Allograft on a Vasculitic Ulcer

San Diego, CA, 4

56 y.o. male with bilateral, medial, and lateral foot ulcers associated with cryoglobulinemia, vasculitis, and severe inflammation.  Additional patient medical history showed renal insufficiency, hepatitis C, depressive disorder NEC, insomnia, hypertension, and hypogonadism.

The patient’s wounds had been present for more than 1 year, unresponsive to all forms of conservative therapy and gradually increasing in size.  Previous wound treatments included topical alginates, collagen dressings, collagenase, petrolatum gauze, and moist saline gauze.  All previous topical therapies had failed.

Half of the wound was covered with a Human Allograft based product, with the other half covered by a Stabilized ECM.

  • After 16 weeks of treatment, the wound treated with the Human Allograft based product remained open with no healing properties remaining after 4th week.
  • Just 1 application healed the wound in 14 weeks.

An optimally stabilized collagen-based xenograft, by its ability to withstand the destructive activity of proteolytic enzymes, appears able to create an environment conducive to healing. It is conceivable that the stabilized collagen (in the xenograft) reduced the rate and length of the inflammatory processes associated with continued presence of digested collagen eptides…

The reduction in pain experienced by this patient also suggests a role played by the biologic in altering additional inflammatory processes in the wound bed, a significant consideration when treating asculitic ulcers.

As Mulder et al stated. ³

Initial Pre-Op Presentation

Left foot medial side, presenting high levels of pain as well as extensive tissue and underlying tendon necrosis.

Medial left foot 2 weeks Post-Surgery

Anterior wound site, Human Allograft dissolved in the wound.

Posterior wound site, Stabilized ECM starting to close.

4 weeks Post-Surgery

Anterior wound site, No Human Allograft remaining.

Posterior wound site, Stabilized ECM remains intact, site closing.

14 weeks Post-Surgery

Anterior (Human Allograft) Wound site, remains open (un-healed).

Posterior (Stabilized ECM) wound site, wound closed (healed).

16 weeks Post-Surgery

Anterior (Human Allograft) Wound site, remains open and unhealed.

Posterior (Stabilized ECM) wound site, remains closed.


Pressure Ulcer with Exposed Tendon

Atlanta, GA.

59 y.o. Diabetic male with Pressure Ulcer and tendon exposed for 2 months. Preliminary recommendation was amputation. Instead a stabilized ECM was applied and used in conjunction with NPWT. Just 1 application resulted in 90% healing at 9 weeks.

Pre-Application

Pressure Ulcer with exposed tendon, facing possible amputation.

Initial Application

A Stabilized ECM was applied
(only 1 application was needed).

9 Weeks Post-Op

Wound nearly healed, amputation avoided.


Chronic Amputation Site Wound

Pre-Application

5 year old Chronic Ulcer.

Post Application

Four Weeks Post-Application
(single application).

*Dressing darkened due to silver applied on top of of the dressing.

Post Application

Four Weeks Post-Application
(single application).

*Dressing pealed back to reveal granulation and re-epithelialization.

Learn more about the Mechanism of Action Study at OSU

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Stabilized ECM Clinical Studies

A number of studies have been published about the use of stabilized extracellular collagen matrix for treating chronic skin wounds, including:

Equine Pericardium Collagen Wound Dressing in the Treatment of the Neuropathic Diabetic Foot Wound: A Pilot Study.

Fleischli, JG, et al. ¹

  • 23 consecutive patients; 34 foot wounds at one center
  • Median wound size 299 mm²
  • ECM applied if wound was = 4 weeks old, removed at +2.9 weeks (mean)
  • At 4 weeks, 52.3% reduction in size
  • At 12 weeks, 15 wounds (47%) had fully healed

Equine Pericardium as a Biological Covering for the Treatment of Diabetic Foot Wounds.

Alexander, JH, et al. ²

  • 34 patients; 37 foot wounds at 2 centers
  • Mean wound size 716 mm2
  • Stabilized ECM applied if wound was at least 4 weeks old, and ECM was left on the wound
  • At 12 weeks, 28 wounds (75.7%) had fully healed
  • 36 of the 37 wounds were treated with a single application
  • Non-healed wounds had a reduction in wound size that ranged from 29% to 80%

A retrospective clinical review of extracellular matrices for tissue reconstruction: equine pericardium as a biological covering to assist with wound closure.

Mulder, G et al. ³

  • 24 wounds (DFU, VLU, trauma) in 24 patients from previously failed therapy
  • Duration of the wound prior to application of stabilized ECM ranged from 3 months to 2 years
  • Median time to wound closure was 6 weeks (2-9 weeks)

References:

1. Fleischli JG, Laughlin TJ, Fleischli JW. Equine pericardium collagen wound dressing in the treatment of neuropathic diabetic foot wound: A Pilot Study. J Am Podiatric Assoc., 2009 Jul-Aug:99(4):301-305.

2. Yeager DA, Alexander JH, et al. Equine Pericardium as a Biological Covering for the Treatment of Diabetic Foot Wounds: A Prospective Study. J Am Podiatric Assoc., 2012 Sep-Oct.:102 (5): 352-358.

3. Mulder G, Lee D. A retrospective clinical review of extracellular matices for tissue reconstruction: equine pericardium as a biological covering to assist with wound closure. Wounds 21: 254, 2009.

4. Mulder G, Lee D, Case Presentation: Xenograft Resistance to Protease Degradation in a Vasculitic Ulcer, Int J Low Extrem Wounds, 2009, 8 (3), p. 157.

*Referenced studies are for informational purposes only. This site is for informational purposes only and is not intended as a substitute for professional medical advice.  See Architect® Instructions for Use for approved indications and instructions.  Architect® is a registered trademark of Harbor MedTech, Inc., Steri-Strips® are a registered trademark of 3M, Inc.  All rights reserved.

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