SCIENTIFIC EVIDENCE The clinical trials reported in this section have sound methodologies; at least a control group and all have been published in peer review scientific journals.
LLLT produced in vitro increases in cell growth of 140-200% in mouse-derived fibroblasts, rat-derived osteoblasts and rat-derived skeletal muscle cells, and increased by 155-171% growth of normal human epithelial cells. Wound size decreased up to 36% in conjunction with hyperbaric oxygen HBO in ischemic rat models. LLLT produced improvement of greater than 40% in musculoskeletal training injuries, and decreased wound healing time. LLLT reduced by 47% pain of children suffering from oral mucositisi[i].
In vitro, LLLT inhibits bacterial growth of E.coli, Staphylococcus aureus and Pseudomonas aeruginosaii[ii].
A randomized double-blind placebo-controlled clinical trial, on thirty consecutive patients with diabetic ulcers or gangrenes and elevated levels of glycosylated haemoglobin, has demonstrated an increase in skin microcirculation due to LLLT, which was an athermic effect, in patients with diabetic microangiopathyiii[iii]. A clinical trial of LLLT, with the combined use of HBO, showed 81% healing of diabetic foot ulcers in patients who previously did not respond to a comprehensive treatment program. The authors conclude that this modality is safe, simple and inexpensiveiv[iv].
A placebo-controlled clinical trial, studying the efficacy of combined phototherapy with LLLT in the management of venous ulceration when used in conjunction with standardized nursing intervention, showed clinical difference in wound healing rate and a continued reduction in wound size at post-irradiationv[v]. A double-blind, placebo- controlled clinical trial of low energy photon therapy (LEPT) (Red and Infrared) in venous leg ulcers showed a decrease in ulcer area (compared to baseline) of 193.0 mm2 in the LEPT group and of 14.7 mm2 in the placebo group respectively (P = 0.0002) vi[vi].
A randomized, controlled study examined the effects of infrared and red pulsed monochromatic light with varied pulsations and wavelengths, in addition to standard treatment, on the healing of pressure ulcers. Patients treated with pulsed monochromatic light had a 49% higher ulcer healing rate, their mean ulcer area was reduced to 10% after 5 weeks compared with 9 weeks for the controlsvii[vii].
A controlled clinical trial of patients with two pressure ulcers (one for polarised light, one as control) examined the effect of polarized light on pressure ulcers of 1st, 2nd and 3rd grades. Pressure ulcers subjected to extra treatment with polarized light in the early stages showed significantly greater improvement in the healing process than the control ulcersviii[viii].
Pulsed high-frequency, high peak power electromagnetic energy has been shown to increased healing time in patients with Stage II ulcers unhealed within three to 12 weeks and those with Stage III ulcers unhealed within eight to 168 weeks by conventional methods. Stage II ulcers healed in one to six weeks (mean 2.33) and all Stage III ulcers healed in one to 22 weeks (mean 8.85)ix[ix]. CASE STUDIES
Case # 1.
79 year old female, personal history of dementia and osteoporosis. A fall from her bed on 06 January 2004 resulted in a large skin tear. Due to her dementia, she pulled the dressings off and painted lipstick around the wound. With the introduction of the LLLT, programs 2 & 4 on 30 April 2004, and wound protocol of Intrasite gel, the wound had healed by the 20 May 2004. Case #1 before start of TerraQuant Treatment
Case #1 after 3 ½ weeks of TerraQuant Treatment
79 year old female, with PHX of IDDM, blindness, amputation of (L) toes (11 Feb 2000) and (R) middle toe amputation (June 1999). An ulcer developed on her left foot in May 2001 and she was sent to Hospital for investigation for Gangrene. A sinus developed within the original wound on 20 Jul 2001 which we continued to pack with Kaltostat; and eventually the wound healed. In Feb 2002, the wound returned. Wound specialist was consulted and a full felt pad was recommended to reduce the pressure. On 21 Oct 2003, pus was expelled and sinus noted. The patient was again hospitalized and her diagnosis of Cellulitis was treated with A/B’s. The caregiver continued to dress the wound daily from October 2003 with no signs of improvement.
On 30 Apr 2004 the wound was measured at 2.8cm x 2.8cm. TerraQuant treatment was commenced using programs 2 & 4. By 17 May 2004 the size had reduced to 1.8cm x 0.8cm. On the 06 Jun 2004, the patient was referred to the Podiatrist who applied felt to reduce pressure. By 16 Jun 2004, without changing the dressing protocol, the wound had decreased to be measured at 0.7cm x 0.3cm. Wound re-measured 29 Jun 2004 at 0.7cm x 0.1cm. The attending physician was very impressed with the outcome, particularly given the patient’s history.
before start of TerraQuant Treatment after 1 ½ month of TerraQuant Treatment
After 2 ½ months of TerraQuant treatments
94 year old female, with a past history of Multiple Sclerosis, Arthritis and repetitious Leg Venous Ulcers. This lady complained of severe pain in her left and right knees and a raised rash was noted on her left leg.
TerraQuant Programs 1 (5Hz) & 3 (1000Hz) treatments were introduced on 10 May 2004 and the rash was resolved within 3 days. On the 18 Jun 2004, the resident complained of pain in her (R) shoulder and on examination by her
General Practitioner, she was diagnosed with a ruptured tendon. Laser treatment was recommended. Treatment was continued on all three areas using programs 1 & 3 with a positive result. Pain was reduced and she now has the ability to ambulate more freely. Long term MS Contin was prescribed in conjunction with programs 1 & 3. Case # 4.
79 year old female, has a debilitating PHx of rheumatoid arthritis, osteoarthritis and joint replacements. Her current medication was ineffective in managing her pain. The use of TerraQuant over acutely painful areas of (L) shoulder, (L) clavicle and (L) humerous with programs 1 & 3 has proven to provide pain relief and as a result, treatment will be ongoing. Case # 5.
94 year old female suffering from heart disease and bilateral oedema. This lady sustained an enormous skin tear to her (L) leg on 04 May 2004 following a fall. In view of her existing oedema with serous ooze and taking Warfarin and Prednisolone she was transferred to hospital for suturing. Wound measured 14.9cm x 8cm.
She was returned to her nursing home on 11 May 2004 on A/B’s. Sutures were removed on 13th and 14th of May wound had broken down, now measuring 12cm x 6cm (14 May 2004). TerraQuant treatment was commenced on 20 May 2004 in conjunction with wound management of intrasite gel, tegaderm and compression stockings. On 01 Jun 2004 wound had increased in length due to the tegaderm causing superficial breakdown. Wound measurements 13cm x 4cm. Tegaderm was ceased, and daily dressing with intrasite gel, melonin, combine and compression stockings.
16 June 2004 Cellulitis has reduced even though oedema is still present. Wound has decreased again to be 6cms x 2.7cm. Daily TerraQuant treatment continued and the wound was dressed with Duoderm extra thin and left intact for 5 days. Staff continued to apply compression stockings. 29 Jun 2004, the wound measured 4.9cm x 1.2cms. Wound is granulating upwards even with surrounding skin. Area of slough has decreased significantly and surrounding skin is now pink and healthy with serous ooze at a minimum. Staff continues to apply compression stocking to aid fluid return. Case # 6
An 80 year old lady with a Left Hip pressure ulcer 3cm x 3cm x 1cm which had been deteriorating rapidly for two weeks. The ulcer was sloughy, and necrotic. The resident is very demented and reacts strongly when dressings are redressed (pushes staff away). TerraQuant initiated daily on 14 April 2004.
60% sloughy, 30% necrotic, 10% granulation.
50% sloughy, 50% granulation, marked reduction in odour.
2cm x 3cm, depth 0.5 cm at sloughy end of wound.
Wound clean and reduced in size 2cm x 2cm, sinus cavity patent.
Wound closing. 1cm opening. Gauze wick in place to keep sinus patent. Patient has no reaction or complaints when dressing changed.
Case # 7 This resident is an 81-year-old woman with multiple systems failure with very frail and thin skin. Fall on 19 May 2004 with multiple skin tears on the L hand, R & L knees and R ankle and 7cm long laceration to the scalp. The skin tear to the knees had no skin left to put a flap back into place. The treatment consisted of an initial dressing on the scalp and the other skin tears. Steristips were applied, and dressed with Solugel, Interpose and Mefix. TerraQuant was used through the dressing on the scalp and knees for seven days, one 10-minute session daily.
All tears healed in 5 to 7 days. The Director of Nursing said: “We would have expected all tears to take at least 3 to 4 weeks to heal. One advantage was to be able to give the LLLT treatments through the dressings without having to change them daily and without disturbing the patient.” Case # 8
This resident is an 86-year-old lady with very frail and thin skin who keeps rubbing her two feet/ankles together. As a consequence, her Left Foot displayed abrasions that, if she had kept rubbing, were at risk of never healing.
TerraQuant treatments were given daily for 7 days. The abrasions healed. The resident ceased rubbing her feet together. The Director of Nursing said: “We would have expected to need 3 to 4 weeks of wound management and protective dressing necessary to overcome her abrasions.” Case # 9
This resident is a very frail 86-year-old woman with multiple diseases. She is currently on various medications including Prednisolone. She also has poor dietary intake and is supplemented with a high calorie and protein drink. She developed a leg haematoma (12cm x 3cm), from locking and rubbing her legs together, which was at risk of breaking down.
TerraQuant treatments were given daily for 7 days. Healing was achieved. The Director of Nursing said: “We would have expected the haematoma to break down and due to her compromised health status we would have expected any breakdown of the skin integrity would take an extended period to heal”. Case # 10
This resident is an 86-year-old lady who is legally blind and has substantial hearing loss. She ambulates with difficulty with a four-wheeled frame. She has moderate cognitive impairment, requires prompting and displays short-term memory loss. She takes multiple medications, including Warfarin. She has a long history of lower leg ulcers which never heal completely.
One leg ulcer 6cm x 2cm has been present since early March 2004 and had shown little progress in healing, despite applying daily dressings of Jelonet, Solugel, Kaltostat and two full courses of antibiotics.
On 14 April 2004 daily TerraQuant treatments were initiated with Melonin or Cutilin dressings only. By 16 June 2004, the ulcer had completely healed.
This resident is a 97-year-old lady who has multiple diseases (AF, CCF, OA, Gout, Rotator cuff syndrome on one side and fractured neck of humerus on the other side, moderate cognitive impairment, and significant and constant oedemas in the lower legs).
She walks with difficulty with a 4-wheeled frame. On 21 January 2004, she injured her right lower calf against one of the footplates of a wheelchair. She sustained a V shaped cut of 6 cm length. She received daily dressings with Kaltostat, Solugel and Jelonet. She received several courses of antibiotics. Medihoney was tried. The wound was very slouchy and necrotic. Daily TerraQuant treatments were initiated on 18 March 2004. By late April the wound had completely healed. Before introducing the TerraQuant treatments, the resident had the tendency to try to remove dressings, which inhibited the healing process. After receiving a few treatments with TerraQuant, the wound dried out, no dressing was necessary and the resident stopped picking at the wound.
This resident is an 88-year-old lady who sustained a 9cm jagged deep pre-tibia wound on her L shin. The wound was sutured but the borders did not anastomose well. The skin was very thin and frail. Daily TerraQuant treatments were initiated two days after the injury and the sutures. One week later when the sutures were removed, the wound had completely healed. There was no oozing, no signs of infection and no redness. The wound had healed as with normal health skin. The Director of Nursing said: We would have expected the wound to get infected and remain open after the stitches were removed and for the wound to take several months to heal.
This resident is an 83-year-old lady with multiple diseases including IDDM, moderate to severe cognitive impairment, Breast Cancer with Mastectomy and radiotherapy many years ago. Her skin is very frail and ruptures easily.
Her cognitive impairment made her very non-compliant and erratic with her medication and her insulin in particular. She was transferred from home to an acute care hospital on 3 February 2004 for unbalanced IDDM. A mastectomy line infected wound was then identified and wound management initiated.
She was transferred from acute hospital to residential care on 4 March 2004. She then had two wounds at the mastectomy site: one wound was 5cm x 2cm full thickness; and the other wound was 2cm x 2cm full thickness. Both wounds were very sloughy.
Daily TerraQuant treatments were initiated on 19 March 2004. By 28 May 2004, the smaller of the two wounds had healed completely and the large wound was reduced to 1cm x 1cm granulating, with no slouch or necrosis.
Unfortunately, for reasons beyond control, TerraQuant treatments were ceased from 28 May 2004 until 18 June 2004. Over this time, both wounds deteriorated significantly due to friction caused by the patient when showering and drying herself with a towel.
GRAPHY i[i] Whelan, H.T. et al, J. Clin. Laser Med. Surg. 19:305, 2001. ii[ii] Nussbaum, E.L. et al, Clin. Laser Med. Surg. 20:325, 2002 iii[iii]
Schindl, A., et al, Low-intensity laser irradiation improves skin circulation in patients with diabetic microangiopathy. Diabetes Care, 21:580, 1998
Landau, Z. and Schattner, A. Yale J. Biol. Med. 74:95, 2001
v[v] Legan, K.M. et al, J. Clin. Laser Med. Surg. 20:109, 2002. vi[vi]
Gupta AK, et al. The use of low energy photon therapy (LEPT) in venous leg ulcers: a double-blind, placebo-controlled study.Dermatol Surg 1998 Dec;24(12):1383-6
Schubert V. Effects of phototherapy on pressure ulcer healing in elderly patients after a falling trauma. A prospective, randomized, controlled study. Photodermatol Photoimmunol
viii[viii] Lordanou P, et al. Effect of polarized light in the healing process of pressure ulcers. Int J Nurs Pract 2002 Feb;8(1):49-55 ix[ix] Itoh M, et al. Accelerated wound healing of pressure ulcers by pulsed high peak power electromagnetic energy (Diapulse). Decubitus 1991 Feb;4(1):24-5, 29-34
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